Home / 510(k) Clearances / K880388

510(k) K880388

T3 SEROZYME ENZYMEIMMUNOASSAY KIT, MAG SOLID PHASE by Serono Diagnostics, Inc. — Product Code CDP

K880388 is an FDA 510(k) premarket notification submitted by Serono Diagnostics, Inc. for the device "T3 SEROZYME ENZYMEIMMUNOASSAY KIT, MAG SOLID PHASE". The FDA issued a decision of Substantially Equivalent on March 3, 1988. The device falls under product code CDP (Radioimmunoassay, Total Triiodothyronine), a Class II device regulated under 21 CFR 862.1710. Serono Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 1988
Date Received
January 28, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Total Triiodothyronine
Device Class
Class II
Regulation Number
862.1710
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)
  • K883085 — T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHAS (September 9, 1988)
  • K882340 — LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHA (August 8, 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 CDP

  • K001607 — REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104) (October 5, 2000)
  • K991692 — CHIRON DIAGNOSTICS ACS: 180 FT3 (June 18, 1999)
  • K991311 — TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005 (June 2, 1999)
  • K991252 — AIA-PACK FT3 ASSAY (May 11, 1999)
  • K981824 — OPTICOAT T3 EIA KIT (December 22, 1998)
  • K983434 — ABBOTT ARCHITECT TOTAL T3 (November 20, 1998)
  • K983439 — ABBOTT ARCHITECT FREE T3 (November 20, 1998)
  • K974027 — AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK (February 2, 1998)
  • K974634 — IMMULITE FREE T3 (January 2, 1998)
  • K973966 — ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (October 31, 1997)

FDA data resources