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510(k) K911912

SR1 T3 UPTAKE ENZYME IMMUNOASSAY(MAG SOLID-PHASE) by Serono-Baker Diagnostics, Inc. — Product Code KHQ

K911912 is an FDA 510(k) premarket notification submitted by Serono-Baker Diagnostics, Inc. for the device "SR1 T3 UPTAKE ENZYME IMMUNOASSAY(MAG SOLID-PHASE)". The FDA issued a decision of Substantially Equivalent on September 18, 1991. The device falls under product code KHQ (Radioassay, Triiodothyronine Uptake), a Class II device regulated under 21 CFR 862.1715. Serono-Baker Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 1991
Date Received
April 30, 1991
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 Serono-Baker Diagnostics, Inc.

  • K924257 — TESTOSTERONE SEROZYME(TM) ENZYME IMMUNOASSAY (November 30, 1992)
  • K914886 — SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG SOL PHASE) (March 2, 1992)
  • K915164 — SRI TESTOSTERONE ENZYME IMMUNOASSAY (March 2, 1992)
  • K915602 — SRI DIGOXIN ENZYME IMMUNOASSAY (January 17, 1992)
  • K912937 — SR1 FREE T4 ENZYME IMMUNOASSAY (November 19, 1991)
  • K914462 — SRI PROGESTERONE ENZYME IMMUNOASSAY(MAG SOLD PHAS) (October 23, 1991)
  • K911217 — SR1 T4 ENZYME IMMUNOASSAY (MAGNETIC SOLID-PHASE) (August 16, 1991)
  • K912318 — ESTRADIOL SEROZYME ENZYME IMMUNO (MAG SOLID-PHASE) (July 25, 1991)
  • K911396 — SR1 ESTRADIOL ENZYME IMMUNOASSAY (May 28, 1991)
  • K910837 — SRI TSH IMMUNENZYMETRIC ASSAY (May 24, 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