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510(k) K760928

BLOOD BANK DRI-BATH by Thermolyne Corp. — Product Code JTQ

K760928 is an FDA 510(k) premarket notification submitted by Thermolyne Corp. for the device "BLOOD BANK DRI-BATH". The FDA issued a decision of Substantially Equivalent on January 10, 1977. The device falls under product code JTQ (Bath, Incubators/Water, All), a Class I device regulated under 21 CFR 866.2540. Thermolyne Corp. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 1977
Date Received
October 29, 1976
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 Thermolyne Corp.

  • K792095 — HISTO-CENTER II (November 20, 1979)
  • K771617 — SPECI-MIX (September 2, 1977)
  • K770914 — INCUBATOR, PORTABLE, ACT-STAT (August 4, 1977)

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)
  • K812826 — FORMA CH/P GAS PROCESSOR (October 23, 1981)
  • K812340 — TITERTEK MICROPLATE INCUBATOR (September 23, 1981)
  • K801462 — SPOR-O-THERM (July 28, 1980)

FDA data resources