AMNIO-GROW TM— 510(k) K892938

Substantially Equivalent

Inovar Biologicals, Inc.

FDA 510(k) clearance K892938 for AMNIO-GROW TM, Substantially Equivalent on 1989-05-22. Applicant: Inovar Biologicals, Inc.. Device class: 1.

Clearance details

Applicant: Inovar Biologicals, Inc.
Product code: Code KIT
Device class: Class 1
Regulation: 21 CFR 864.2220
Advisory panel: Hematology
Date received: 1989-04-21
Decision date: 1989-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gaithersburg, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KIT

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K890701 — ENDOTHELIAL GROWTH MEDIUM (EGM)1989-02-24
K890482 — ABC, ABC-1X, ABC(TM)1989-02-10
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.