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510(k) K892938

AMNIO-GROW TM by Inovar Biologicals, Inc. — Product Code KIT

K892938 is an FDA 510(k) premarket notification submitted by Inovar Biologicals, Inc. for the device "AMNIO-GROW TM". The FDA issued a decision of Substantially Equivalent on May 22, 1989. The device falls under product code KIT (Media And Components, Synthetic Cell And Tissue Culture), a Class I device regulated under 21 CFR 864.2220.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 1989
Date Received
April 21, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media And Components, Synthetic Cell And Tissue Culture
Device Class
Class I
Regulation Number
864.2220
Review Panel
PA
Submission Type

Other clearances for product code KIT

  • K890701 — ENDOTHELIAL GROWTH MEDIUM (EGM) (February 24, 1989)
  • K890700 — MELANOCYTE GROWTH MEDIUM (MGM) (February 24, 1989)
  • K890482 — ABC, ABC-1X, ABC(TM) (February 10, 1989)
  • K884654 — ALPHACALF SERUM (November 30, 1988)
  • K884573 — HBSS W/O CALC CHLOR/MAG SULF/PHEN RED/SB NO. H4891 (November 22, 1988)
  • K884574 — DME & HAM'S NUTRIENT MIXTURE, PROD. NO. D9785 (November 22, 1988)
  • K884572 — RPMI-1640 HYBRI-MAX, PROD. NO. R5382 (November 22, 1988)
  • K883065 — ALLOPREP SYSTEM (October 13, 1988)
  • K884031 — FBS, EQ., OR FETAL BOVINE SERUM EQUIVALENT (October 6, 1988)
  • K883951 — MEDIUM 199 W/EBSS (CATALOG NO. 200-2037) (September 30, 1988)

FDA data resources