FDA Product Code
FDA Product Code GGK — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.8540
510(k) Clearances — 29 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K883836 | COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-II | Coulter Immunology | 1988-11-30 | Traditional | PDF ↗ |
| K883991 | KVM HEMOGLOBIN LYSING REAGENT | Kvm Technologies, Inc. | 1988-10-12 | Traditional | PDF ↗ |
| K874054 | FISHER DIAGNOSTICS HEMATALL III LAS REAGENT | Fisher Scientific Co., LLC | 1987-10-20 | Traditional | PDF ↗ |
| K873348 | CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG. | Abbott Diagnostics | 1987-09-09 | Traditional | PDF ↗ |
| K863114 | PIASTRINIT | J. D. Assoc. | 1986-11-06 | Traditional | PDF ↗ |
| K863503 | HEMOLYSE | Reagent Laboratory, Inc. | 1986-10-03 | Traditional | PDF ↗ |
| K850097 | LASER-LYSE | Hematology Marketing Assoc. | 1985-03-29 | Traditional | PDF ↗ |
| K850944 | NSI LYSING-D REAGENT -4000 ML | Nobel Scientific Industries, Inc. | 1985-03-29 | Traditional | PDF ↗ |
| K842938 | ACETIC ACID 1% V/V | E K Ind., Inc. | 1984-09-14 | Traditional | PDF ↗ |
| K842935 | ACETIC ACID, 5% V/V | E K Ind., Inc. | 1984-09-12 | Traditional | PDF ↗ |
| K842936 | ACETIC ACID, 3% V/V | E K Ind., Inc. | 1984-09-12 | Traditional | PDF ↗ |
| K842937 | ACETIC ACID 2% V/V | E K Ind., Inc. | 1984-09-12 | Traditional | PDF ↗ |
| K842069 | IDL-LYSING REAGENT | Interscience Diagnostics, Inc. | 1984-07-02 | Traditional | PDF ↗ |
| K841800 | LYSING & HEMOGLOBIN REAGENT | Reagent Laboratory, Inc. | 1984-05-31 | Traditional | PDF ↗ |
| K840289 | LYSE-TEC | Medilab Corp. | 1984-03-05 | Traditional | PDF ↗ |
| K834527 | THROMBO PLUS | W. Sarstedt, Inc. | 1984-01-30 | Traditional | PDF ↗ |
| K833444 | LYSING & HEMOGLOBIN S-REAGENT J & S | Jasins & Sayles Associates, Inc. | 1983-11-03 | Traditional | PDF ↗ |
| K832182 | LYSING REAGENT | Omega Medical Diagnostics | 1983-08-12 | Traditional | PDF ↗ |
| K830186 | LYSIS + | Hematology Marketing Assoc. | 1983-02-28 | Traditional | PDF ↗ |
| K822324 | RED CELL LYSING REAGENT 78N 1915-1 | Interscience, Inc. | 1982-11-08 | Traditional | PDF ↗ |
| K822500 | CDL LYSING REAGENT | Connecticut Diagnostics, Ltd. | 1982-09-17 | Traditional | PDF ↗ |
| K822504 | CDL AUTO-LYSING REAGENT | Connecticut Diagnostics, Ltd. | 1982-09-17 | Traditional | PDF ↗ |
| K812002 | ELUAID | Ortho Diagnostic Systems, Inc. | 1981-10-28 | Traditional | PDF ↗ |
| K802742 | SERA-PAK TOTAL PROTEIN REAGENT | Miles Laboratories, Inc. | 1980-12-11 | Traditional | PDF ↗ |
| K790029 | FLUID, RHEMOX W LYSING | Sysmex Corp. | 1979-02-26 | Traditional | PDF ↗ |
| K782098 | REAGENT, LYSING AND HEMOGLOBIN | Dade, Baxter Travenol Diagnostics, Inc. | 1979-01-17 | Traditional | PDF ↗ |
| K781121 | HEMOLYSE | Electrophoresis Corp. of America | 1978-08-14 | Traditional | PDF ↗ |
| K771788 | CYMET-AUTOMATED | J.T. Baker Chemical Co. | 1977-10-07 | Traditional | PDF ↗ |
| K761182 | ISOTONIC DILUENT AF | Central Labs. Assoc. MD Pathologists | 1976-12-09 | Traditional | PDF ↗ |
Product code GGK · Class I · Hematology. Data: openFDA.