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510(k) K991311

TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005 by Biocheck, Inc. — Product Code CDP

K991311 is an FDA 510(k) premarket notification submitted by Biocheck, Inc. for the device "TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005". The FDA issued a decision of Substantially Equivalent on June 2, 1999. The device falls under product code CDP (Radioimmunoassay, Total Triiodothyronine), a Class II device regulated under 21 CFR 862.1710. Biocheck, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 1999
Date Received
April 16, 1999
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 Biocheck, Inc.

  • K041619 — BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116 (December 17, 2004)
  • K040030 — BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114 (June 16, 2004)
  • K022660 — BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117 (December 19, 2002)
  • K013062 — BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT (January 8, 2002)
  • K003851 — BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL (July 20, 2001)
  • K002294 — BIOCHECK TESTOSTERONE EIA, MODEL BC-1115 (October 2, 2000)
  • K001022 — BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061 (September 26, 2000)
  • K992517 — BIOCHECK FERRITIN ELISA MODEL BC-1025 (September 24, 1999)
  • K992528 — BIOCHECK IGE ELISA, MODEL BC-1035 (September 21, 1999)
  • K991741 — BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027 (July 22, 1999)

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)
  • 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)
  • K971779 — TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA (June 16, 1997)

FDA data resources