Part 864 Subpart E—Specimen Preparation Reagents
FDA submissions for Part 864 Subpart E—Specimen Preparation Reagents in the Pathology (PA) review panel, including product codes, regulations, and recent device decisions.
Section range: §§ 864.4010–864.4400
CFR Part: 864
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| HZI | Acid, Osmic | 864.4010 | 1 | 0 |
| IAL | Iodine (Tincture) | 864.4010 | 1 | 0 |
| IAM | Solution, Lugol'S | 864.4010 | 1 | 0 |
| IAT | Syrup, Gum, Apathy'S | 864.4010 | 1 | 0 |
| IAW | Collodion | 864.4010 | 1 | 0 |
| IAY | Colchicine | 864.4010 | 1 | 0 |
| IBB | Phytohemaglutinin M | 864.4010 | 1 | 0 |
| IER | Polyethylene Glycol (Carbowax) | 864.4010 | 1 | 1 |
| IEX | Gelatin | 864.4010 | 1 | 0 |
| IEZ | Celloidin | 864.4010 | 1 | 0 |
| IFF | Solution, Decalcifier, Electrolytic | 864.4010 | 1 | 0 |
| IFH | Solution, Zenker'S | 864.4010 | 1 | 2 |
| IFI | Sprays, Synthetic, Smear | 864.4010 | 1 | 1 |
| IFJ | Fixative, Richardson Glycol | 864.4010 | 1 | 0 |
| IFL | Polyethylene Glycol Preservative | 864.4010 | 1 | 0 |
| IFN | Solution, Orth'S | 864.4010 | 1 | 0 |
| IFO | Solution, Newcomer'S | 864.4010 | 1 | 0 |
| IFP | Formalin, Neutral Buffered | 864.4010 | 1 | 15 |
| IFQ | Formulations, Mercuric Chloride For Tissue | 864.4010 | 1 | 2 |
| IFS | Solution, Helly | 864.4010 | 1 | 0 |
| IFT | Glutaraldehyde | 864.4010 | 1 | 1 |
| IFY | Gelatin-Formalin | 864.4010 | 1 | 0 |
| IFZ | Gelatin For Specimen Adhesion | 864.4010 | 1 | 1 |
| IGB | Solution, Formalin-Sodium Acetate | 864.4010 | 1 | 1 |
| IGC | Formalin-Saline | 864.4010 | 1 | 2 |
| IGD | Solution, Formol Calcium | 864.4010 | 1 | 0 |
| IGE | Solution, Formalin Ammonium Bromide | 864.4010 | 1 | 2 |
| IGF | Solution, Formalin-Alcohol-Acetic Acid | 864.4010 | 1 | 1 |
| IGG | Formaldehyde (Formalin, Formol) | 864.4010 | 1 | 7 |
| IGK | Solution, Clarke'S | 864.4010 | 1 | 0 |
| IGM | Solution, Carnoy'S | 864.4010 | 1 | 3 |
| IGN | Fluid, Bouin'S | 864.4010 | 1 | 2 |
| IJZ | Oil, Clearing | 864.4010 | 1 | 1 |
| JCB | Detergent | 864.4010 | 1 | 0 |
| JCC | Ph Buffer | 864.4010 | 1 | 7 |
| JCE | Solution, Isotonic | 864.4010 | 1 | 7 |
| KDX | Solution, Decalcifier, Acid Containing | 864.4010 | 1 | 8 |
| KDY | Agent, Chelating For Decalcification | 864.4010 | 1 | 0 |
| KEE | Osmium Tetroxide | 864.4010 | 1 | 0 |
| KEF | Paraformaldehyde | 864.4010 | 1 | 0 |
| KEL | Adhesive, Albumin-Based | 864.4010 | 1 | 2 |
| KEM | Agent, Clearing | 864.4010 | 1 | 15 |
| KEO | Formulations, Paraffin, All | 864.4010 | 1 | 11 |
| KEP | Media, Mounting, Oil Soluble | 864.4010 | 1 | 3 |
| KEQ | Media, Mounting, Water Soluble | 864.4010 | 1 | 7 |
| LDW | Fixative, Acid Containing | 864.4010 | 1 | 4 |
| LDX | Fixative, Metallic Containing | 864.4010 | 1 | 1 |
| LDY | Fixative, Formalin-Containing | 864.4010 | 1 | 1 |
| LDZ | Fixative, Alcohol Containing | 864.4010 | 1 | 8 |
| LEA | Preservative, Cytological | 864.4010 | 1 | 4 |
| LEB | Mounting Media | 864.4010 | 1 | 5 |
| PPM | General Purpose Reagent | 864.4010 | 1 | 16 |
| MVU | Reagents, Specific, Analyte | 864.4020 | 1 | 0 |
| IAZ | Heparin | 864.4400 | 1 | 0 |
| IBA | Streptolysin O | 864.4400 | 1 | 0 |
| IBC | Diastase | 864.4400 | 1 | 0 |
| IBD | Hyaluronidase | 864.4400 | 1 | 0 |
| IBE | Neuramininase (Sialidase) | 864.4400 | 1 | 0 |
| IBF | Papain | 864.4400 | 1 | 0 |
| IBG | Trypsin | 864.4400 | 1 | 2 |
| LIJ | Peroxidase Anti-Peroxidase Immunohistochemical Stain | 864.4400 | 1 | 2 |
Recent Devices
| Record | Device | Applicant | Decision Date |
|---|---|---|---|
| K955363 | INCSTAR HSZ I/II IGG ELISA ASSAY | Incstar Corp. | Jul 24, 1996 |
| K955362 | INCSTAR HSV I/II IGG FAST ELISA ASSAY | Incstar Corp. | Jul 24, 1996 |
| K950560 | SALINE SOLUTINE, STERILE | Busse Hospital Disposables, Inc. | May 30, 1995 |
| K940768 | AD PERFECT | Chimera Research & Chemical, Inc. | Feb 17, 1995 |
| K893772 | TISSUE EMBEDDING MEDIUM | Stephens Scientific | Jun 22, 1989 |
| K890022 | ATS MAYER'S ALBUMIN | Alpha-Tec Systems, Inc. | Jan 10, 1989 |
| K884755 | CONSED FECAL CONCENTRATION SYSTEM | Donald L. Price, Ph.D. | Jan 10, 1989 |
| K883048 | ATS PARA-SET MODIFIED PVA FIXATIVE SOLUTION | Alpha-Tec Systems, Inc. | Aug 17, 1988 |
| K883062 | ATS SCHAUDINN'S FIXATIVE W/ACETIC ACID | Alpha-Tec Systems, Inc. | Aug 4, 1988 |
| K882874 | ZINC FORMALIN | Anatech, Ltd. | Jul 28, 1988 |
| K882268 | ZINC FORMALIN CONCENTRATE | Anatech, Ltd. | Jun 15, 1988 |
| K881922 | CYTOJARS PREFILLED WITH CYTOLOGY PRESERVATIVE | Surgipath Medical Industries, Inc. | May 25, 1988 |
| K881698 | ATS PVA FIXATIVE SOLUTION | Alpha-Tec Systems, Inc. | May 13, 1988 |
| K881659 | TISSUE SECTION ADHESIVE | Surgipath Medical Industries, Inc. | Apr 21, 1988 |
| K881477 | HISTOGRIP & HISTOGRIP GOLD CONCENTRATE/PREDILUTED | Stat Path | Apr 18, 1988 |
| K881282 | XYLENE | Anatech, Ltd. | Apr 5, 1988 |
| K880549 | DIACYTE FIXATIVE SOLUTION | Cytocorp, Inc. | Apr 1, 1988 |
| K874461 | HEMO-SOL | Chem Pharm, Inc. | Dec 4, 1987 |
| K873594 | TIF FECAL TEST | Devetec, Inc. | Sep 29, 1987 |
| K872663 | DRY-FORM | Anatech, Ltd. | Aug 6, 1987 |
| K872625 | DECALCIFYING SOLUTION | Stephens Scientific | Aug 6, 1987 |
| K872140 | (MSI) PATH-SAVER | Medical Specialties, Inc. | Jun 15, 1987 |
| K871533 | TOMTEC GRAM STAINER DECOLORIZER | Remel Co. | Apr 29, 1987 |
| K870852 | NBF 10% NEUTRAL BUFFERED FORMALIN | Anatech, Ltd. | Mar 31, 1987 |
| K863550 | POTASSIUM HYDROXIDE 10% W/V | Reagent Laboratory, Inc. | Oct 2, 1986 |
| K862725 | SACCOMANNO SPECIMAN SOLUTION | Mill-Rose Laboratory | Aug 1, 1986 |
| K862223 | MICRO THIN* PARAFFIN | Richard-Allan Medical Ind., Inc. | Jun 17, 1986 |
| K862141 | HISTOLOGY PARAFFIN | Erie Scientific Co. | Jun 13, 1986 |
| K861890 | 100%, 95%, 80% & 70% DEHYDRANT CUSTOM BLEND NO. 2 | Richard-Allan Medical Ind., Inc. | Jun 3, 1986 |
| K861490 | PERMACLEAR SOLUTION CAT. NO. 4950 | Helena Laboratories | May 6, 1986 |
| K861270 | BLUE RIBBON PARAFFIN INFILTRATION/EMBEDDING MED. | Surgipath Medical Industries, Inc. | Apr 11, 1986 |
| K861201 | FORMALDEHYDE SOLUTION, 37% | Surgipath Medical Industries, Inc. | Apr 11, 1986 |
| K855034 | AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANT | Bartels Immunodiagnostic Supplies, Inc. | Mar 11, 1986 |
| K855109 | CLEARENE, CLEARING AGENT | Surgipath Medical Industries, Inc. | Jan 7, 1986 |
| K853861 | CANON X-RAY I.I. RAPID SEQUENCE CAMERA CRS-105 | Canon USA, Inc. | Oct 24, 1985 |
| K854083 | XYLENE SUBSTITUTE MONTANT | Lerner Laboratories, Inc. | Oct 22, 1985 |
| K853694 | XYLENE SUBSTITUTE | Lerner Laboratories, Inc. | Oct 22, 1985 |
| K853497 | PREFILLED SPECIMEN JARS 10% NEUTRAL BUF-FORMALIN | Surgipath Medical Industries, Inc. | Aug 28, 1985 |
| K852045 | SED-FIX CONCENTRATE | Surgipath Medical Industries, Inc. | Jun 10, 1985 |
| K850916 | SPRAYFIX | Surgipath Medical Industries, Inc. | Mar 25, 1985 |
| K850845 | 0.85% SALINE | Micro Media Laboratories | Mar 20, 1985 |
| K850737 | TRANSPORT CULTURE MEDIUM | Roseville Medical Laboratoriesu | Mar 20, 1985 |
| K850636 | SIMUTANEOUS FIXATION & DECALCIFYING SOLUTION CAL-E | Fisher Scientific Co., LLC | Mar 20, 1985 |
| K842982 | FORMALIN BUFFERED | Reagent Laboratory, Inc. | Oct 1, 1984 |
| K843428 | BIOFIX | Accra Laboratories, Inc. | Sep 27, 1984 |
| K842934 | DECOLORIZING FLUIC, ACID-ALCOHOL 3% | E K Ind., Inc. | Sep 12, 1984 |
| K842923 | PICRIC ACID 1% W/V | E K Ind., Inc. | Sep 11, 1984 |
| K842918 | SCOTTS TAP WATER SUBSTITUTE | E K Ind., Inc. | Sep 11, 1984 |
| K842731 | FORMALIN-ACETO-ALCOHOL FIXATIVE | E K Ind., Inc. | Sep 11, 1984 |
| K842722 | BUFFERED SALINE | E K Ind., Inc. | Sep 11, 1984 |
| K842922 | PICRIC ACID SATURATED SOLUTION | E K Ind., Inc. | Sep 7, 1984 |
| K842914 | WRIGHT STAIN BUFFER | E K Ind., Inc. | Sep 7, 1984 |
| K842913 | WRIGHT STAIN FIXATIVE | E K Ind., Inc. | Sep 7, 1984 |
| K842737 | CARNOY'S SOLUTION | E K Ind., Inc. | Sep 7, 1984 |
| K842940 | CBA FORMALIN | Anatech, Ltd. | Aug 28, 1984 |
| K842862 | CB FORMALIN | Anatech, Ltd. | Aug 28, 1984 |
| K842986 | REFRAX MOUNTING MEDIUM | Anatech, Ltd. | Aug 21, 1984 |
| K842863 | PRO-SOFT DEHYDRANT | Anatech, Ltd. | Aug 21, 1984 |
| K842861 | PRO-PAR CLEARANT | Anatech, Ltd. | Aug 21, 1984 |
| K842732 | ZENKERS SOLUTION | E K Ind., Inc. | Aug 3, 1984 |
| K842729 | DECOLORIZING FLUID | E K Ind., Inc. | Aug 3, 1984 |
| K842728 | BUF-FIX | E K Ind., Inc. | Aug 3, 1984 |
| K842726 | DECALCIFIER SOLUTION | E K Ind., Inc. | Aug 3, 1984 |
| K842721 | LIMONENE | E K Ind., Inc. | Aug 3, 1984 |
| K842070 | IDD DETERGENT | Interscience Diagnostics, Inc. | Jul 2, 1984 |
| K842053 | PARAPLAST EXTRA TISSUE EMBEDDING MED. | Sherwood Medical Co. | Jun 26, 1984 |
| K841423 | SCOTTS TAP WATER SUBSTITUTE 7 | Reagent Laboratory, Inc. | May 22, 1984 |
| K841488 | DECALCIFIER I | Surgipath Medical Industries, Inc. | May 2, 1984 |
| K840926 | FORMALIN SOLUTION 10% NEUTRAL BUFFER | Sigma Chemical Co. | Mar 12, 1984 |
| K833515 | BOUINS SOLUTION | Sigma Chemical Co. | Nov 14, 1983 |
| K833071 | TECHNICON PARACUT | Technicon Instruments Corp. | Oct 14, 1983 |
| K832451 | CLEAR-RITE 3 | Richard-Allan Medical Ind., Inc. | Aug 12, 1983 |
| K832011 | AMERI CLEAR | Stephens Scientific | Aug 12, 1983 |
| K831620 | SODIUM HYPOCHLORITE 3% | Omega Medical Diagnostics | Jul 28, 1983 |
| K831619 | SODIUM HYPOCHLORITE 7% | Omega Medical Diagnostics | Jul 28, 1983 |
| K831580 | PARAFFIN INFILTRATION MEDIUM | Surgipath Medical Industries, Inc. | Jun 17, 1983 |
| K831061 | PVA FIXATIVE/FORMALIN | American Micro Scan | Jun 8, 1983 |
| K831058 | SAF FIXATIVE | American Micro Scan | Jun 8, 1983 |
| K831200 | IMMUNOHEMATOLOGICAL SALINE #97139 | Emd Chemicals, Inc. | May 9, 1983 |
| K830515 | SCOTTS TAP WATER SUBSTITUTE CONCENTRATE | Surgipath Medical Industries, Inc. | Mar 31, 1983 |
| K830627 | CLARIFIER-RICHARD-ALLAN | Richard-Allan Medical Ind., Inc. | Mar 24, 1983 |
| K830659 | CLEARIUM, MOUNTING MEDIUM | Surgipath Medical Industries, Inc. | Mar 17, 1983 |
| K830583 | NEUTRAL BUFFERED FORMALIN 10% | Surgipath Medical Industries, Inc. | Mar 17, 1983 |
| K830582 | MILLONIG'S MODIFIED PHOSPHATE BUFFERED | Surgipath Medical Industries, Inc. | Mar 17, 1983 |
| K830514 | MILLONIGS MODIFIED PHOSPHATE BUFFERED | Surgipath Medical Industries, Inc. | Mar 8, 1983 |
| K822784 | HEMO-DE | Pmp Industries | Nov 5, 1982 |
| K822326 | BLENDED DETERGENT-78N 1912-1 | Interscience, Inc. | Oct 18, 1982 |
| K822129 | VOLU-SOL BOVINS FIXATIVE | Volu Sol Medical Industries | Aug 5, 1982 |
| K822127 | VOLU-SOL ZENKERS FIXATIVE | Volu Sol Medical Industries | Aug 5, 1982 |
| K822126 | VOLU-SOL CARNOY FLUID | Volu Sol Medical Industries | Aug 5, 1982 |
| K822037 | VOLU-SOL TAP WATER SUBSTITUTE | Volu Sol Medical Industries | Aug 3, 1982 |
| K822036 | VOLU-SOL DECALCIFER | Volu Sol Medical Industries | Aug 3, 1982 |
| K820336 | DAKO PAP KIT K509 | Dako Corp. | Jul 13, 1982 |
| K821443 | FORMICAL | Lerner Laboratories, Inc. | Jun 2, 1982 |
| K821019 | PHOSPHATE BUFFERED CLYCEROL MOUNTING FLU | Microbiological Research Corp. | Apr 26, 1982 |
| K812940 | 10% NEUTRAL BUFFERED FORMALIN CONCENT | Surgipath | Dec 10, 1981 |
| K812817 | NEUTRAL DUFFERED FORMA-SCENT | Meridian Diagnostics, Inc. | Nov 10, 1981 |
| K812847 | XYLENE | Richard-Allan Medical Ind., Inc. | Oct 29, 1981 |
| K812846 | CLEAR-RITE II | Richard-Allan Medical Ind., Inc. | Oct 29, 1981 |
| K812193 | KOH MOUNTING FLUID | American Scientific Products | Aug 31, 1981 |
