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510(k) K812820

CHANG MEDIUM by Hana Biologics, Inc. — Product Code KIT

K812820 is an FDA 510(k) premarket notification submitted by Hana Biologics, Inc. for the device "CHANG MEDIUM". The FDA issued a decision of Substantially Equivalent on November 10, 1981. 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. Hana Biologics, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 1981
Date Received
October 7, 1981
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 by Hana Biologics, Inc.

  • K883682 — CHANG MEDIUM (ADDITIONAL INDICATIONS) (September 16, 1988)
  • K855205 — MYCOTRIM TM VL TRIPHASIC CULTURE SYSTEM (February 5, 1986)
  • K834616 — AMNIO STAT-FLM AGGLUTINATION TEST (May 25, 1984)
  • K833933 — ACE COLOR TEST (March 23, 1984)
  • K822736 — MYCOTRIUM-GU (December 3, 1982)
  • K822737 — MYCOTRIUM-RS (December 3, 1982)
  • K822150 — AMNISTAT-FLM (October 21, 1982)

Other clearances for product code KIT

  • K892938 — AMNIO-GROW TM (May 22, 1989)
  • 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)

FDA data resources