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510(k) K851738

MCDB-105 MED. M6395, W/L-GLUTAMINE, 25M M HERPES & by Sigma — Product Code KIT

K851738 is an FDA 510(k) premarket notification submitted by Sigma for the device "MCDB-105 MED. M6395, W/L-GLUTAMINE, 25M M HERPES &". The FDA issued a decision of Substantially Equivalent on May 15, 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. Sigma has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1985
Date Received
April 25, 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 Sigma

  • K962239 — SMART ADJUSTER (SA201) (January 10, 1997)
  • K926191 — SIGMA 7000 AND SIGMA70002 (August 31, 1993)
  • K851737 — MCDB-110 MED. M6520 W/L-GLUTAMINE-25M M HERPES & (May 15, 1985)
  • K820038 — SIGMA 7000 (January 26, 1983)
  • K830038 — SIGMA 7000-6000 INFUSION PUMPS (January 26, 1983)

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