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510(k) K791662

IMMUCHEM COVALENT COAT BINDING by Immuchem Corp. — Product Code KHQ

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
Radioassay, Triiodothyronine Uptake
Device Class
Class II
Regulation Number
862.1715
Review Panel
CH
Submission Type

Other clearances by Immuchem Corp.

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  • 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)

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  • K961488 — ELECSYS T-UPTAKE ASSAY (June 12, 1996)
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  • K933414 — STRATUS(R) THYROID UPTAKE FLUOR ENZYME IMMUNOASSAY (November 22, 1994)
  • K934312 — AXSYM(TM) T-UPTAKE (June 21, 1994)
  • K935816 — VIDAS T UPTAKE (March 22, 1994)