Home / 510(k) Clearances / K850510

510(k) K850510

EMEM W/NEAA-MINIMUM ESSENTIAL MED. W/NON-ESS. AMIN by Mediatech, Inc. — Product Code KIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 1985
Date Received
February 8, 1985
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 Mediatech, Inc.

  • K860623 — CELLGRO HEPES BUFFER SOLUTION (March 3, 1986)
  • K854567 — PENICILLIN/STREPTOMYCIN SOLUTION (December 6, 1985)
  • K852602 — MCCOY'S 5A MEDIUM-LIQUID FORM (July 12, 1985)
  • K852485 — CELLGRO(ISCOVE'S MEDIUM) MODIFICATION (July 12, 1985)
  • K852603 — MCCOY'S 5A MEDIUM - POWDERED FORM (July 12, 1985)
  • K852475 — CELLGRO WILLIAMS' MEDIUM E (July 12, 1985)
  • K852288 — CELLGRO (June 4, 1985)
  • K850515 — HAM'S F-10-A SPEC. FORMULATION FROM DR. HAM (February 27, 1985)
  • K850522 — MEM VITAMINS-MINIMUM ESSENTIAL MEDIUM VITAMINS (February 27, 1985)
  • K850511 — EMEM-EARLE'S MINIMUM ESSENTIAL MED. W/GLUTAMINE-EA (February 27, 1985)

Other clearances for product code KIT

  • K892938 — AMNIO-GROW TM (May 22, 1989)
  • K890700 — MELANOCYTE GROWTH MEDIUM (MGM) (February 24, 1989)
  • K890701 — ENDOTHELIAL GROWTH MEDIUM (EGM) (February 24, 1989)
  • K890482 — ABC, ABC-1X, ABC(TM) (February 10, 1989)
  • K884654 — ALPHACALF SERUM (November 30, 1988)
  • K884572 — RPMI-1640 HYBRI-MAX, PROD. NO. R5382 (November 22, 1988)
  • K884574 — DME & HAM'S NUTRIENT MIXTURE, PROD. NO. D9785 (November 22, 1988)
  • K884573 — HBSS W/O CALC CHLOR/MAG SULF/PHEN RED/SB NO. H4891 (November 22, 1988)
  • K883065 — ALLOPREP SYSTEM (October 13, 1988)
  • K884031 — FBS, EQ., OR FETAL BOVINE SERUM EQUIVALENT (October 6, 1988)