GGK
29 FDA 510(k) clearances · Product code
40 daysmedian time to decision
85 days90th percentile
29clearances measured
FDA profile
- Official device name
- Products, Red-Cell Lysing Products
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.8540
- Medical specialty
- Hematology
- Adverse events (MAUDE)
- 1996: 1 · 2010: 10 · 2011: 60
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-II (K883836) | Coulter Immunology | 1988-11-30 |
| KVM HEMOGLOBIN LYSING REAGENT (K883991) | Kvm Technologies, Inc. | 1988-10-12 |
| FISHER DIAGNOSTICS HEMATALL III LAS REAGENT (K874054) | Fisher Scientific Co., LLC | 1987-10-20 |
| CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG. (K873348) | Abbott Diagnostics | 1987-09-09 |
| PIASTRINIT (K863114) | J. D. Assoc. | 1986-11-06 |
| HEMOLYSE (K863503) | Reagent Laboratory, Inc. | 1986-10-03 |
| NSI LYSING-D REAGENT -4000 ML (K850944) | Nobel Scientific Industries, Inc. | 1985-03-29 |
| LASER-LYSE (K850097) | Hematology Marketing Assoc. | 1985-03-29 |
| ACETIC ACID 1% V/V (K842938) | E K Ind., Inc. | 1984-09-14 |
| ACETIC ACID 2% V/V (K842937) | E K Ind., Inc. | 1984-09-12 |
| ACETIC ACID, 3% V/V (K842936) | E K Ind., Inc. | 1984-09-12 |
| ACETIC ACID, 5% V/V (K842935) | E K Ind., Inc. | 1984-09-12 |
| IDL-LYSING REAGENT (K842069) | Interscience Diagnostics, Inc. | 1984-07-02 |
| LYSING & HEMOGLOBIN REAGENT (K841800) | Reagent Laboratory, Inc. | 1984-05-31 |
| LYSE-TEC (K840289) | Medilab Corp. | 1984-03-05 |
| THROMBO PLUS (K834527) | W. Sarstedt, Inc. | 1984-01-30 |
| LYSING & HEMOGLOBIN S-REAGENT J & S (K833444) | Jasins & Sayles Associates, Inc. | 1983-11-03 |
| LYSING REAGENT (K832182) | Omega Medical Diagnostics | 1983-08-12 |
| LYSIS + (K830186) | Hematology Marketing Assoc. | 1983-02-28 |
| RED CELL LYSING REAGENT 78N 1915-1 (K822324) | Interscience, Inc. | 1982-11-08 |
| CDL LYSING REAGENT (K822500) | Connecticut Diagnostics, Ltd. | 1982-09-17 |
| CDL AUTO-LYSING REAGENT (K822504) | Connecticut Diagnostics, Ltd. | 1982-09-17 |
| ELUAID (K812002) | Ortho Diagnostic Systems, Inc. | 1981-10-28 |
| SERA-PAK TOTAL PROTEIN REAGENT (K802742) | Miles Laboratories, Inc. | 1980-12-11 |
| FLUID, RHEMOX W LYSING (K790029) | Sysmex Corp. | 1979-02-26 |
| REAGENT, LYSING AND HEMOGLOBIN (K782098) | Dade, Baxter Travenol Diagnostics, Inc. | 1979-01-17 |
| HEMOLYSE (K781121) | Electrophoresis Corp. of America | 1978-08-14 |
| CYMET-AUTOMATED (K771788) | J.T. Baker Chemical Co. | 1977-10-07 |
| ISOTONIC DILUENT AF (K761182) | Central Labs. Assoc. MD Pathologists | 1976-12-09 |
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Every clearance here is in the API, with alerts when new ones post.