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510(k) K931294

IQ TUPTAKE ASSAY by Becton Dickinson Advanced Diagnostics — Product Code KHQ

K931294 is an FDA 510(k) premarket notification submitted by Becton Dickinson Advanced Diagnostics for the device "IQ TUPTAKE ASSAY". The FDA issued a decision of Substantially Equivalent on July 22, 1993. The device falls under product code KHQ (Radioassay, Triiodothyronine Uptake), a Class II device regulated under 21 CFR 862.1715. Becton Dickinson Advanced Diagnostics has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 1993
Date Received
March 15, 1993
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 Becton Dickinson Advanced Diagnostics

  • K935667 — QTEST(R) STREP (April 21, 1994)
  • K931295 — IQ TT4 ASSAY (July 20, 1993)
  • K926356 — PRECISE(TM) HCG(URINE/SERUM) AND PRCISE(TM) PREG (March 18, 1993)
  • K925132 — BECTON DICKINSON THYROID STIMULATING HORMONE SYSTE (December 28, 1992)
  • K923673 — PRECISE STREP A (September 28, 1992)
  • K923060 — IQ IMMUNOCHEMISTRY SISTEM; IQ TSH ASSAY (September 15, 1992)
  • K914958 — RIATRAC PLUS (March 18, 1992)
  • K915197 — PRECISE TM HCG (December 17, 1991)
  • K915200 — PRECISE TM HCG FOR USE IN THE PHYSICIANS OFFICE LA (December 16, 1991)

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