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510(k) K892224

D-CHEM(TM) T-UPTAKE TEST KIT FOR T-UPTAKE DETERMIN by Photec Diagnostics, Inc. — Product Code KHQ

K892224 is an FDA 510(k) premarket notification submitted by Photec Diagnostics, Inc. for the device "D-CHEM(TM) T-UPTAKE TEST KIT FOR T-UPTAKE DETERMIN". The FDA issued a decision of Substantially Equivalent on June 16, 1989. The device falls under product code KHQ (Radioassay, Triiodothyronine Uptake), a Class II device regulated under 21 CFR 862.1715. Photec Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1989
Date Received
April 3, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioassay, Triiodothyronine Uptake
Device Class
Class II
Regulation Number
862.1715
Review Panel
CH
Submission Type

Other clearances by Photec Diagnostics, Inc.

  • K897169 — QUIKREAD(R) WHOLE BLOOD TRIGLYCERIDE TEST KIT (February 23, 1990)
  • K896329 — D-CHEM TOTAL T4 TEST KIT FOR THYROXINE QUANTITA. (December 12, 1989)
  • K894057 — QUIKREAD WHOLE BLOOD HDL-CHOLESTEROL TEST KIT (August 31, 1989)
  • K890267 — QUIKREAD CHEM. ANALYZER & CHOLES. FOR SERUM/PLASMA (April 26, 1989)
  • K890027 — QUIKREAD CHEM. ANALYZER & CHOLES. FOR WHOLE BLOOD (April 26, 1989)
  • K882307 — D-CHEM (August 2, 1988)
  • K880291 — THEOPHYLLINE TEST KIT REF. #A874799 (March 24, 1988)
  • K854875 — APO-SCREEN CALIBRATOR & CONTROL SET FOR HDL APO A1 (January 24, 1986)
  • K853048 — APO-SCREEN TEST SET FOR HDL-APOLIPOPTEIN A-1 (August 28, 1985)
  • K853174 — APO-CHROME IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN (August 22, 1985)

Other clearances for product code KHQ

  • K981375 — ACE T UPTAKE REAGENT TU CALIBRATORS (June 10, 1998)
  • K980088 — T-UPTAKE MICROPLATE EIA (February 4, 1998)
  • K970539 — CHIRON DIAGNOSTICS ACS:180TU P (March 24, 1997)
  • K964308 — VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAK (November 27, 1996)
  • K961488 — ELECSYS T-UPTAKE ASSAY (June 12, 1996)
  • K954807 — CEDIA T UPTAKE ASSAY (December 21, 1995)
  • K951586 — T-UPTAKE EIA TEST (May 15, 1995)
  • K933414 — STRATUS(R) THYROID UPTAKE FLUOR ENZYME IMMUNOASSAY (November 22, 1994)
  • K934312 — AXSYM(TM) T-UPTAKE (June 21, 1994)
  • K935816 — VIDAS T UPTAKE (March 22, 1994)

FDA data resources