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510(k) K821919

POWDERED RPMI-1634 MEDIUM by Dutchland Laboratories, Inc. — Product Code KIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1982
Date Received
June 28, 1982
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 Dutchland Laboratories, Inc.

  • K821914 — COON'S F-12 POWDER MEDIUM (July 27, 1982)
  • K821915 — BME AUTOCLAVABLE MEDIUM (July 27, 1982)
  • K821912 — MCCOY'S POWDER MEDIUM 5A SUSPENSION (July 27, 1982)
  • K821911 — S-MEM-JOKLIK'S POWDER (July 27, 1982)
  • K821916 — IMPROVED MEM-RICHTER'S POWDER MODIF. (July 27, 1982)
  • K821918 — POWDERED RPMI-1603 MEDIUM (July 27, 1982)
  • K821913 — ISCOVE'S MODIFIED DULBECCO POWDER MEDIUM (July 27, 1982)
  • K821917 — WAYMOUTH'S POWDER MEDIUM (July 27, 1982)
  • K820930 — FISCHER'S POWDERED MEDIUM (April 21, 1982)
  • K820914 — EMEM POWERED MEDIUM (April 21, 1982)

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)