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510(k) K902748

SEROZYME FREE T3 IMMUNOASSAY by Advanced Magnetics, Inc. — Product Code KHQ

K902748 is an FDA 510(k) premarket notification submitted by Advanced Magnetics, Inc. for the device "SEROZYME FREE T3 IMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on August 9, 1990. The device falls under product code KHQ (Radioassay, Triiodothyronine Uptake), a Class II device regulated under 21 CFR 862.1715. Advanced Magnetics, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 1990
Date Received
June 22, 1990
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 Advanced Magnetics, Inc.

  • K900060 — FREE T4 IMMUNOASSAY KIT (March 29, 1990)
  • K894200 — FREE T3 RADIOIMMUNOASSAY KIT (September 25, 1989)
  • K884753 — MODIFIED FREE T4 RADIOIMMUNOASSAY KIT (February 27, 1989)

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