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510(k) K812617

VITROGEN TM 100 by Collagen Corp. — Product Code KIT

K812617 is an FDA 510(k) premarket notification submitted by Collagen Corp. for the device "VITROGEN TM 100". The FDA issued a decision of Substantially Equivalent on October 2, 1981. 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. Collagen Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 1981
Date Received
September 15, 1981
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 Collagen Corp.

  • K904671 — QAR HANDPIECE (December 21, 1990)
  • K904228 — OSSEODENT DENTAL ATTACHMENTS (NON-ANGLED) (November 9, 1990)
  • K901600 — OSSEOTITE IRRIGATION UNIT (June 21, 1990)
  • K900275 — OSSEODENT DENTAL ATTACHMENT, IGLOO MAGNET (April 19, 1990)
  • K895462 — OSSEODENT DENTAL ATTACHMENTS (April 4, 1990)
  • K895463 — OSSEODENT(R) PRECISION DENTAL ATTACHMENTS (March 28, 1990)
  • K894331 — OSSEODENT SURGICAL KIT (October 4, 1989)
  • K883322 — DENTAL HAND INSTRUMENTS (August 26, 1988)

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