BGM CELL CULTURE— 510(k) K943886

Substantially Equivalent

Neogenex

FDA 510(k) clearance K943886 for BGM CELL CULTURE, Substantially Equivalent on 1994-11-28. Applicant: Neogenex. Device class: 1.

Clearance details

Applicant: Neogenex
Product code: Code KIR
Device class: Class 1
Regulation: 21 CFR 864.2280
Advisory panel: Hematology
Date received: 1994-08-09
Decision date: 1994-11-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Everett, WA, 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 Neogenex

K965047 — MINK LUNG CELL CULTURE1997-02-04
K960909 — H292 CELL CULTURE1996-05-30
K943884 — PRIMARY MONKEY KIDNEY CELL CULTURE1994-11-28
K943885 — PRIMARY RABBIT KIDNEY CELL CULTURE1994-11-28
K943887 — HUMAN NEWBORN FORESKIN CELL CULTURE1994-11-28

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