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510(k) K850990

HFF GENCELLS by Bioassay Systems Research Corp. — Product Code KIT

K850990 is an FDA 510(k) premarket notification submitted by Bioassay Systems Research Corp. for the device "HFF GENCELLS". The FDA issued a decision of Substantially Equivalent on April 12, 1985. 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. Bioassay Systems Research Corp. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 1985
Date Received
March 11, 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 Bioassay Systems Research Corp.

  • K780869 — CELL CULTURE LINES (August 14, 1978)
  • K771867 — MYCOPLASMA DETECTION KIT (November 17, 1977)

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