VERO GENCELLS— 510(k) K851927

Substantially Equivalent

Genus Diagnostics

FDA 510(k) clearance K851927 for VERO GENCELLS, Substantially Equivalent on 1985-05-20. Applicant: Genus Diagnostics. Device class: 1.

Clearance details

Applicant: Genus Diagnostics
Product code: Code KIR
Device class: Class 1
Regulation: 21 CFR 864.2280
Advisory panel: Hematology
Date received: 1985-05-02
Decision date: 1985-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woburn, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KIR

K973209 — FRESH CELLS VERO1997-09-25
K973210 — FRESH CELLS NCI H2921997-09-25
K973211 — FRESH CELLS MV1LU1997-09-25
K973212 — FRESH CELLS WI-381997-09-25
K973213 — FRESH CELLS LLC-MK21997-09-25

More clearances from Genus Diagnostics

K854974 — HSV IDR1986-03-07
K852204 — MCCOY GENCELLS1985-06-04
K852205 — RMK GENCELLS CULTURE SYSTEM1985-06-04
K852206 — HEP-2 GENCELLS1985-06-04
K851928 — HEK GENCELLS1985-05-20

Data sourced from openFDA. This site is unofficial and independent of the FDA.