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510(k) K812826

FORMA CH/P GAS PROCESSOR by Forma Scientific, Inc. — Product Code JTQ

K812826 is an FDA 510(k) premarket notification submitted by Forma Scientific, Inc. for the device "FORMA CH/P GAS PROCESSOR". The FDA issued a decision of Substantially Equivalent on October 23, 1981. The device falls under product code JTQ (Bath, Incubators/Water, All), a Class I device regulated under 21 CFR 866.2540. Forma Scientific, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1981
Date Received
October 8, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bath, Incubators/Water, All
Device Class
Class I
Regulation Number
866.2540
Review Panel
MI
Submission Type

Other clearances by Forma Scientific, Inc.

  • K841631 — MODEL 3014 SUCTION UNIT (July 3, 1984)
  • K823356 — READY-BOX BODY-TEMP MEDIA WARMER MALLIN- (December 3, 1982)
  • K821401 — MALLINCKRODT DIAG. MEDIA WARMER (June 17, 1982)

Other clearances for product code JTQ

  • K875275 — WINTHROP PHARMACEUTICALS CONTRAST MEDIA WARMER (January 27, 1988)
  • K853379 — PLATE INCUBATOR (September 3, 1985)
  • K831592 — ANHYDRIC INCUBATORS, CULTURE INCUBATOR (June 16, 1983)
  • K830322 — C.A.T. REAGENT KIT (March 28, 1983)
  • K830227 — AUTOMATED ELISA READER LBI 300 (March 10, 1983)
  • K830405 — LBI-100 37DEGREES INCUBATOR (March 10, 1983)
  • K822564 — WATER BATH (September 14, 1982)
  • K812340 — TITERTEK MICROPLATE INCUBATOR (September 23, 1981)
  • K801462 — SPOR-O-THERM (July 28, 1980)
  • K792060 — TEMPTRONIC 100 WATER BATH (December 4, 1979)

FDA data resources