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510(k) K883085

T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHAS by Serono Diagnostics, Inc. — Product Code KHQ

K883085 is an FDA 510(k) premarket notification submitted by Serono Diagnostics, Inc. for the device "T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHAS". The FDA issued a decision of Substantially Equivalent on September 9, 1988. The device falls under product code KHQ (Radioassay, Triiodothyronine Uptake), a Class II device regulated under 21 CFR 862.1715. Serono Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1988
Date Received
July 22, 1988
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 Diagnostics, Inc.

  • K953598 — SERIES 9100 PLUS AUTOMATED DIFFERENTIAL HEMATOLOGY ANALYZERS (March 11, 1996)
  • K942051 — SR1 DHEA-S ENZYME IMMUNOASSAY (July 13, 1994)
  • K882340 — LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHA (August 8, 1988)
  • K880388 — T3 SEROZYME ENZYMEIMMUNOASSAY KIT, MAG SOLID PHASE (March 3, 1988)
  • K874866 — T4 SEROZYME ENZYMEIMMUNOASSAY KIT/MAG. SOLID PHASE (February 11, 1988)
  • K873431 — PROGESTERONE MAIA RADIOIMMUNO ASSAY KIT MAG SLD PH (October 20, 1987)
  • K873186 — LH MAIACLONE IMMUNORADIO. ASSAY KIT, MAG SOLID PHA (September 29, 1987)
  • K873400 — PROLACTIN MAIACLONE IMMUNORADIO. KIT, MAG SOL PHA (September 25, 1987)
  • K872862 — PRL SEROZYME IMMUNOENZ. ASSAY KIT, MAG. SOLID PHAS (September 18, 1987)
  • K873033 — HCG SEROZYME IMMUNOENZYM ASSAY KIT/MAG SOLID PHASE (September 14, 1987)

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