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510(k) K791664

IMMUCHEM COVALENT COAT SOLID PHASE ASSAY by Immuchem Corp. — Product Code CDX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1979
Date Received
August 21, 1979
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 Immuchem Corp.

  • K883726 — THYROID STIMULATING HORMONE (HTSH) IRMA NEONATAL (December 15, 1988)
  • K871317 — FOLLICLE STIMULATING HORMONE (HFSH) (May 20, 1987)
  • K871542 — HPROLACTIN KIT (May 14, 1987)
  • K865071 — THYROID STIMULATING HORMONE (TSH IRMA) RIA KIT (March 13, 1987)
  • K864144 — LUTEINIZING HORMONE (LH-IRMA) RIA KIT (November 24, 1986)
  • K860559 — ANDROSTENEDIONE 125I KIT BY RIA (March 14, 1986)
  • K854094 — IMMUCHEM COVALENT COAT A SOLID PHASE RADIOIMMUNOAS (February 28, 1986)
  • K830962 — IMMUCHEM COVALENT-COAT RIA KIT (May 4, 1983)
  • K822509 — COVALENT COAT RIA KIT (September 28, 1982)
  • K822140 — IMMUCHEM COVALENT-COAT (August 5, 1982)

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)