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510(k) K833016

TISSUE TRANSPORT MEDIUM by Northern Scientific, Inc. — Product Code KIT

K833016 is an FDA 510(k) premarket notification submitted by Northern Scientific, Inc. for the device "TISSUE TRANSPORT MEDIUM". The FDA issued a decision of Substantially Equivalent on October 14, 1983. 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. Northern Scientific, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 1983
Date Received
September 6, 1983
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 Northern Scientific, Inc.

  • K883854 — DEXSOL (November 16, 1988)
  • K854052 — CSM MEDIUM (December 31, 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)
  • 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)
  • 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