Panels › Hematology › Product code GGK · Class 1
Products, Red-Cell Lysing Products
Regulation 864.8540
0510(k)s in 12 months (29 all time)
0recalls in 12 months (7 all time)
1recalls that name a 510(k)
Top companies in GGK
| Company | 510(k)s | Recalls |
|---|---|---|
| E K Ind., Inc. | 4 | 0 |
| Beckman Coulter Inc. | 0 | 3 |
| Connecticut Diagnostics, Ltd. | 2 | 0 |
| Hematology Marketing Assoc. | 2 | 0 |
| Reagent Laboratory, Inc. | 2 | 0 |
| Sysmex America, Inc. | 0 | 2 |
| Abbott Diagnostics | 1 | 0 |
| Abbott Laboratories | 0 | 1 |
| Central Labs. Assoc. MD Pathologists | 1 | 0 |
| Coulter Immunology | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 30, 1988 | K883836 | COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-II Coulter Immunology | GGK |
| Oct 12, 1988 | K883991 | KVM HEMOGLOBIN LYSING REAGENT Kvm Technologies, Inc. | GGK |
| Oct 20, 1987 | K874054 | FISHER DIAGNOSTICS HEMATALL III LAS REAGENT Fisher Scientific Co., LLC | GGK |
| Sep 9, 1987 | K873348 | CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG. Abbott Diagnostics | GGK |
| Nov 6, 1986 | K863114 | PIASTRINIT J. D. Assoc. | GGK |
| Oct 3, 1986 | K863503 | HEMOLYSE Reagent Laboratory, Inc. | GGK |
| Mar 29, 1985 | K850944 | NSI LYSING-D REAGENT -4000 ML Nobel Scientific Industries, Inc. | GGK |
| Mar 29, 1985 | K850097 | LASER-LYSE Hematology Marketing Assoc. | GGK |
| Sep 14, 1984 | K842938 | ACETIC ACID 1% V/V E K Ind., Inc. | GGK |
| Sep 12, 1984 | K842937 | ACETIC ACID 2% V/V E K Ind., Inc. | GGK |
| Sep 12, 1984 | K842936 | ACETIC ACID, 3% V/V E K Ind., Inc. | GGK |
| Sep 12, 1984 | K842935 | ACETIC ACID, 5% V/V E K Ind., Inc. | GGK |
| Jul 2, 1984 | K842069 | IDL-LYSING REAGENT Interscience Diagnostics, Inc. | GGK |
| May 31, 1984 | K841800 | LYSING & HEMOGLOBIN REAGENT Reagent Laboratory, Inc. | GGK |
| Mar 5, 1984 | K840289 | LYSE-TEC Medilab Corp. | GGK |
| Jan 30, 1984 | K834527 | THROMBO PLUS W. Sarstedt, Inc. | GGK |
| Nov 3, 1983 | K833444 | LYSING & HEMOGLOBIN S-REAGENT J & S Jasins & Sayles Associates, Inc. | GGK |
| Aug 12, 1983 | K832182 | LYSING REAGENT Omega Medical Diagnostics | GGK |
| Feb 28, 1983 | K830186 | LYSIS + Hematology Marketing Assoc. | GGK |
| Nov 8, 1982 | K822324 | RED CELL LYSING REAGENT 78N 1915-1 Interscience, Inc. | GGK |
| Sep 17, 1982 | K822504 | CDL AUTO-LYSING REAGENT Connecticut Diagnostics, Ltd. | GGK |
| Sep 17, 1982 | K822500 | CDL LYSING REAGENT Connecticut Diagnostics, Ltd. | GGK |
| Oct 28, 1981 | K812002 | ELUAID Ortho Diagnostic Systems, Inc. | GGK |
| Dec 11, 1980 | K802742 | SERA-PAK TOTAL PROTEIN REAGENT Miles Laboratories, Inc. | GGK |
| Feb 26, 1979 | K790029 | FLUID, RHEMOX W LYSING Sysmex Corp. | GGK |
| Jan 17, 1979 | K782098 | REAGENT, LYSING AND HEMOGLOBIN Dade, Baxter Travenol Diagnostics, Inc. | GGK |
| Aug 14, 1978 | K781121 | HEMOLYSE Electrophoresis Corp. of America | GGK |
| Oct 7, 1977 | K771788 | CYMET-AUTOMATED J.T. Baker Chemical Co. | GGK |
| Dec 9, 1976 | K761182 | ISOTONIC DILUENT AF Central Labs. Assoc. MD Pathologists | GGK |
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