GGK · Products, Red-Cell Lysing Products
Hematology · 21 CFR 864.8540 · Class 1
Overview
| Product Code | GGK |
|---|---|
| Device Name | Products, Red-Cell Lysing Products |
| Regulation | 21 CFR 864.8540 |
| Device Class | Class 1 |
| Review Panel | Hematology |
Identification
A red cell lysing reagent is a device used to lyse (destroy) red blood cells for hemoglobin determinations or aid in the counting of white blood cells.
Classification Rationale
Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Recent Cleared Devices (20 of 29)
Showing 20 most recent of 29 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K883836 | COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-II | Coulter Immunology | Nov 30, 1988 | SESE |
| K883991 | KVM HEMOGLOBIN LYSING REAGENT | Kvm Technologies, Inc. | Oct 12, 1988 | SESE |
| K874054 | FISHER DIAGNOSTICS HEMATALL III LAS REAGENT | Fisher Scientific Co., LLC | Oct 20, 1987 | SESE |
| K873348 | CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG. | Abbott Diagnostics | Sep 9, 1987 | SESE |
| K863114 | PIASTRINIT | J. D. Assoc. | Nov 6, 1986 | SESE |
| K863503 | HEMOLYSE | Reagent Laboratory, Inc. | Oct 3, 1986 | SESE |
| K850944 | NSI LYSING-D REAGENT -4000 ML | Nobel Scientific Industries, Inc. | Mar 29, 1985 | SESE |
| K850097 | LASER-LYSE | Hematology Marketing Assoc. | Mar 29, 1985 | SESE |
| K842938 | ACETIC ACID 1% V/V | E K Ind., Inc. | Sep 14, 1984 | SESE |
| K842937 | ACETIC ACID 2% V/V | E K Ind., Inc. | Sep 12, 1984 | SESE |
| K842936 | ACETIC ACID, 3% V/V | E K Ind., Inc. | Sep 12, 1984 | SESE |
| K842935 | ACETIC ACID, 5% V/V | E K Ind., Inc. | Sep 12, 1984 | SESE |
| K842069 | IDL-LYSING REAGENT | Interscience Diagnostics, Inc. | Jul 2, 1984 | SESE |
| K841800 | LYSING & HEMOGLOBIN REAGENT | Reagent Laboratory, Inc. | May 31, 1984 | SESE |
| K840289 | LYSE-TEC | Medilab Corp. | Mar 5, 1984 | SESE |
| K834527 | THROMBO PLUS | W. Sarstedt, Inc. | Jan 30, 1984 | SESE |
| K833444 | LYSING & HEMOGLOBIN S-REAGENT J & S | Jasins & Sayles Associates, Inc. | Nov 3, 1983 | SESE |
| K832182 | LYSING REAGENT | Omega Medical Diagnostics | Aug 12, 1983 | SESE |
| K830186 | LYSIS + | Hematology Marketing Assoc. | Feb 28, 1983 | SESE |
| K822324 | RED CELL LYSING REAGENT 78N 1915-1 | Interscience, Inc. | Nov 8, 1982 | SESE |
Top Applicants
- E K Ind., Inc. — 4 clearances
- Connecticut Diagnostics, Ltd. — 2 clearances
- Hematology Marketing Assoc. — 2 clearances
- Reagent Laboratory, Inc. — 2 clearances
- Abbott Diagnostics — 1 clearance
