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510(k) K920766

T4 EIA BEAD ASSAY by Tech-Co, Inc. — Product Code CDX

K920766 is an FDA 510(k) premarket notification submitted by Tech-Co, Inc. for the device "T4 EIA BEAD ASSAY". The FDA issued a decision of Substantially Equivalent on April 17, 1992. The device falls under product code CDX (Radioimmunoassay, Total Thyroxine), a Class II device regulated under 21 CFR 862.1700. Tech-Co, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 1992
Date Received
February 19, 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 Tech-Co, Inc.

  • K921968 — IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TEST (June 28, 1996)
  • K923376 — VISUAL HCG PREGNANCY TEST (October 1, 1992)
  • K920716 — DIRECT PREGNANCY TEST (March 24, 1992)
  • K902574 — POTASSIUM REAGENT SET (July 10, 1990)
  • K901561 — IRON/TOTAL IRON BINDING CAPACITY (May 17, 1990)
  • K883387 — ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD) (October 13, 1988)
  • K883683 — HEMOGLOBIN (October 6, 1988)
  • K883386 — CHLORIDE (October 6, 1988)
  • K881172 — BILIRUBIN (DIRECT) (June 7, 1988)
  • K881173 — ASPARTATE AMINOTRANSFERASE (COLORIMETRIC METHOD) (June 7, 1988)

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)
  • K926563 — AUTOBEAD(TM) T4 ENZYME IMMUNOASSAY TEST KIT (March 18, 1993)
  • K925110 — ABBOTT IMX T4 (January 26, 1993)
  • K925109 — ABBOTT TDX/TDXFLX TT4 (January 4, 1993)

FDA data resources