Product code GGK— Hematology
HEMOLYSE
- Classification name
- Products, Red-Cell Lysing Products
- Device class
- Class 1
- Regulation
- 21 CFR 864.8540
- Advisory panel
- Hematology
- Total cleared
- 29
- First cleared
- Most recent
Market context for product code GGK
FDA has cleared devices under product code GGK between 1976 and 1988, filed by 23 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 1988
- 1987
- 1986
- 1985
- 1984
- 1983
- 1982
- 1981
- 1980
- 1979
- 1978
- 1977
- 1976
Top applicants under product code GGK
Recent clearances under product code GGK
- K883836 — COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-II
- K883991 — KVM HEMOGLOBIN LYSING REAGENT
- K874054 — FISHER DIAGNOSTICS HEMATALL III LAS REAGENT
- K873348 — CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG.
- K863114 — PIASTRINIT
- K863503 — HEMOLYSE
- K850097 — LASER-LYSE
- K850944 — NSI LYSING-D REAGENT -4000 ML
- K842938 — ACETIC ACID 1% V/V
- K842935 — ACETIC ACID, 5% V/V
- K842936 — ACETIC ACID, 3% V/V
- K842937 — ACETIC ACID 2% V/V
- K842069 — IDL-LYSING REAGENT
- K841800 — LYSING & HEMOGLOBIN REAGENT
- K840289 — LYSE-TEC
- K834527 — THROMBO PLUS
- K833444 — LYSING & HEMOGLOBIN S-REAGENT J & S
- K832182 — LYSING REAGENT
- K830186 — LYSIS +
- K822324 — RED CELL LYSING REAGENT 78N 1915-1
- K822500 — CDL LYSING REAGENT
- K822504 — CDL AUTO-LYSING REAGENT
- K812002 — ELUAID
- K802742 — SERA-PAK TOTAL PROTEIN REAGENT
- K790029 — FLUID, RHEMOX W LYSING
- K782098 — REAGENT, LYSING AND HEMOGLOBIN
- K781121 — HEMOLYSE
- K771788 — CYMET-AUTOMATED
- K761182 — ISOTONIC DILUENT AF
Data sourced from openFDA. This site is unofficial and independent of the FDA.