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510(k) K770914

INCUBATOR, PORTABLE, ACT-STAT by Thermolyne Corp. — Product Code KQG

K770914 is an FDA 510(k) premarket notification submitted by Thermolyne Corp. for the device "INCUBATOR, PORTABLE, ACT-STAT". The FDA issued a decision of Substantially Equivalent on August 4, 1977. The device falls under product code KQG (Instrument, Coagulation), a Class II device regulated under 21 CFR 864.5400. Thermolyne Corp. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 1977
Date Received
May 19, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Coagulation
Device Class
Class II
Regulation Number
864.5400
Review Panel
HE
Submission Type

Other clearances by Thermolyne Corp.

  • K792095 — HISTO-CENTER II (November 20, 1979)
  • K771617 — SPECI-MIX (September 2, 1977)
  • K760928 — BLOOD BANK DRI-BATH (January 10, 1977)

Other clearances for product code KQG

  • K050821 — COAGCARE ANTICOAGULATION MANAGEMENT SYSTEM (August 16, 2005)
  • K021976 — FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON (October 25, 2002)
  • K992130 — PACIFIC HEMOSTASIS THROMBOSCREEN 400C (September 3, 1999)
  • K991321 — PACIFIC HEMOSTASIS THROMBOSCREEN 200 (June 21, 1999)
  • K983475 — HEMOCHRON RESPONSE (May 3, 1999)
  • K902614 — ELVI 828 DIGICLOT MULTISCAN (November 8, 1990)
  • K900685 — CLOT 2 SEMIAUTOMATIC COAGULATION ANALYZER (April 16, 1990)
  • K862047 — COAGULATOR (8 CHANNEL) (September 29, 1986)
  • K852492 — COAGULATOR (August 13, 1985)
  • K851169 — ELECTRA 800 AUTOMATIC COAGULATION TIMER (June 24, 1985)

FDA data resources