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510(k) K926563

AUTOBEAD(TM) T4 ENZYME IMMUNOASSAY TEST KIT by Bio-Chem Laboratory Systems, Inc. — Product Code CDX

K926563 is an FDA 510(k) premarket notification submitted by Bio-Chem Laboratory Systems, Inc. for the device "AUTOBEAD(TM) T4 ENZYME IMMUNOASSAY TEST KIT". The FDA issued a decision of Substantially Equivalent on March 18, 1993. The device falls under product code CDX (Radioimmunoassay, Total Thyroxine), a Class II device regulated under 21 CFR 862.1700. Bio-Chem Laboratory Systems, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 1993
Date Received
December 31, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Total Thyroxine
Device Class
Class II
Regulation Number
862.1700
Review Panel
CH
Submission Type

Other clearances by Bio-Chem Laboratory Systems, Inc.

  • K945271 — ATAC 8000 RANDOM ACCESS CHEMISTRY SYSTEM (April 20, 1995)
  • K930689 — AUTOBEAD THYROID UPTAKE (November 10, 1993)
  • K930006 — AUTOBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT (September 9, 1993)
  • K924084 — ATAC 6000 CHEMISTRY ANALYZER (September 29, 1992)

Other clearances for product code CDX

  • K961490 — ELECSYS T4 ASSAY (June 13, 1996)
  • K954312 — ACTIVE THYROXINE RIA (October 7, 1995)
  • K943416 — DELFIA NEONATAL THYROXINE KIT (March 10, 1995)
  • K934384 — AXSYM(TM) TOTAL T4 (June 21, 1994)
  • K932980 — TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116 (October 18, 1993)
  • K933426 — STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO (August 26, 1993)
  • K931295 — IQ TT4 ASSAY (July 20, 1993)
  • K925110 — ABBOTT IMX T4 (January 26, 1993)
  • K925109 — ABBOTT TDX/TDXFLX TT4 (January 4, 1993)
  • K922945 — TECHNICON DAX SYSTEM THYROXINE (T4) METHOD (October 14, 1992)

FDA data resources