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510(k) K832712

FOLATE RADIOASSAY KIT CA-1562-125 by Clinical Assays, Inc. — Product Code CGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 1983
Date Received
August 12, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acid, Folic, Radioimmunoassay
Device Class
Class II
Regulation Number
862.1295
Review Panel
CH
Submission Type

Other clearances by Clinical Assays, Inc.

  • K832711 — VITAMIN B12 FOLATE CA-1515-125 (October 4, 1983)
  • K832710 — VITAMIN B12 RADIOASSAY KIT CA-1534 (October 4, 1983)
  • K823476 — GAMMADAB LH RADIO-KIT #CA-1508 (December 28, 1982)
  • K823313 — IN VITRO GAMMACOAT B-HCG RADIO. TEST (December 22, 1982)
  • K821611 — GAMMADAB [125] FSH RADIOIMMUNAY KIT (June 24, 1982)
  • K821092 — GAMMADAB[125]EGE RADIOIMMUNOASSAY IT (June 22, 1982)
  • K812227 — GAMMACOAT (125) INSULIN RADIOIMMUNOASSAY (September 24, 1981)
  • K810722 — GASTRIN RADIOIMMUNOASSAY TEST (May 27, 1981)
  • K810967 — IN-VITRO TBG RADIOIMMUNOASSAY TEST (April 23, 1981)
  • K801667 — GAMMA COAT(125 I) RUBELLA ANTIBODY (October 23, 1980)

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