ABC, ABC-1X, ABC(TM)— 510(k) K890482

Substantially Equivalent

Cell Ent., Inc.

FDA 510(k) clearance K890482 for ABC, ABC-1X, ABC(TM), Substantially Equivalent on 1989-02-10. Applicant: Cell Ent., Inc.. Device class: 1.

Clearance details

Applicant: Cell Ent., Inc.
Product code: Code KIT
Device class: Class 1
Regulation: 21 CFR 864.2220
Advisory panel: Hematology
Date received: 1989-01-31
Decision date: 1989-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Derwood, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KIT

K892938 — AMNIO-GROW TM1989-05-22
K890700 — MELANOCYTE GROWTH MEDIUM (MGM)1989-02-24
K890701 — ENDOTHELIAL GROWTH MEDIUM (EGM)1989-02-24
K884654 — ALPHACALF SERUM1988-11-30
K884572 — RPMI-1640 HYBRI-MAX, PROD. NO. R53821988-11-22

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