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510(k) K781482

ORTHO*T-3 UPTAKE KIT by Ortho Diagnostics, Inc. — Product Code KHQ

K781482 is an FDA 510(k) premarket notification submitted by Ortho Diagnostics, Inc. for the device "ORTHO*T-3 UPTAKE KIT". The FDA issued a decision of Substantially Equivalent on September 27, 1978. The device falls under product code KHQ (Radioassay, Triiodothyronine Uptake), a Class II device regulated under 21 CFR 862.1715. Ortho Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1978
Date Received
August 28, 1978
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 Ortho Diagnostics, Inc.

  • K802404 — ORTHO BOVINE ALBUMIN SOLUTION 30% PROTE (October 23, 1980)
  • K801507 — ANTIGEN CONTROL CELLS (August 20, 1980)
  • K800357 — BI-LEVEL ASSAYED CARD. DRUG CONT., I,II (April 16, 1980)
  • K800310 — ORTHO ANTISERA CONTROL (March 5, 1980)
  • K791791 — ORTHO ANTIBODY ENHANCEMENT SOLUTION (October 11, 1979)
  • K791301 — ORTHO TSH RIA KIT (September 24, 1979)
  • K790813 — MULTECON BLOOD GAS CONTROL (June 28, 1979)
  • K782063 — PREGNANCY, SENSIDEX TUBE TEST (April 4, 1979)
  • K782166 — SLIDE TEST FOR PREGNANCY, GRAVINDEX 90 (April 4, 1979)
  • K781638 — RUBINDEX*DIRECT SYSTEM (December 20, 1978)

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