KEO · Formulations, Paraffin, All
Pathology · 21 CFR 864.4010 · Class 1
Overview
| Product Code | KEO |
|---|---|
| Device Name | Formulations, Paraffin, All |
| Regulation | 21 CFR 864.4010 |
| Device Class | Class 1 |
| Review Panel | Pathology |
| GMP Exempt | Yes |
Identification
A general purpose reagent is a chemical reagent that has general laboratory application, that is used to collect, prepare, and examine specimens from the human body for diagnostic purposes, and that is not labeled or otherwise intended for a specific diagnostic application. It may be either an individual substance, or multiple substances reformulated, which, when combined with or used in conjunction with an appropriate analyte specific reagent (ASR) and other general purpose reagents, is part of a diagnostic test procedure or system constituting a finished in vitro diagnostic (IVD) test. General purpose reagents are appropriate for combining with one or more than one ASR in producing such systems and include labware or disposable constituents of tests; but they do not include laboratory machinery, automated or powered systems. General purpose reagents include cytological preservatives, decalcifying reagents, fixative and adhesives, tissue processing reagents, isotonic solutions and pH buffers. Reagents used in tests for more than one individual chemical substance or ligand are general purpose reagents (e.g., Thermus aquaticus (TAQ) polymerase, substrates for enzyme immunoassay (EIA)).
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (11 of 11)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K893772 | TISSUE EMBEDDING MEDIUM | Stephens Scientific | Jun 22, 1989 | SESE |
| K862223 | MICRO THIN* PARAFFIN | Richard-Allan Medical Ind., Inc. | Jun 17, 1986 | SESE |
| K862141 | HISTOLOGY PARAFFIN | Erie Scientific Co. | Jun 13, 1986 | SESE |
| K861270 | BLUE RIBBON PARAFFIN INFILTRATION/EMBEDDING MED. | Surgipath Medical Industries, Inc. | Apr 11, 1986 | SESE |
| K842053 | PARAPLAST EXTRA TISSUE EMBEDDING MED. | Sherwood Medical Co. | Jun 26, 1984 | SESE |
| K833071 | TECHNICON PARACUT | Technicon Instruments Corp. | Oct 14, 1983 | SESE |
| K831580 | PARAFFIN INFILTRATION MEDIUM | Surgipath Medical Industries, Inc. | Jun 17, 1983 | SESE |
| K812191 | VASPAR SEALENT | American Scientific Products | Aug 31, 1981 | SESE |
| K810568 | PARAFFIN EMBEDDING MEDIUM | Surgipath Medical Industries, Inc. | Mar 17, 1981 | SESE |
| K803241 | HISTOLOGICAL EMBEDDING MEDIA | Miles Laboratories, Inc. | Jan 28, 1981 | SESE |
| K760602 | SORVALL EMBEDDING MEDIUM | E.I. Dupont DE Nemours & Co., Inc. | Sep 21, 1976 | SESE |
Top Applicants
- Surgipath Medical Industries, Inc. — 3 clearances
- Technicon Instruments Corp. — 1 clearance
- Stephens Scientific — 1 clearance
- Sherwood Medical Co. — 1 clearance
- Richard-Allan Medical Ind., Inc. — 1 clearance
