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510(k) K772111

IN VITRO PHENOBARBITAL RIA TEST by Clinical Assays, Inc. — Product Code DKP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 1977
Date Received
November 7, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Phenobarbital
Device Class
Class II
Regulation Number
862.3660
Review Panel
TX
Submission Type

Other clearances by Clinical Assays, Inc.

  • K832712 — FOLATE RADIOASSAY KIT CA-1562-125 (October 4, 1983)
  • K832710 — VITAMIN B12 RADIOASSAY KIT CA-1534 (October 4, 1983)
  • K832711 — VITAMIN B12 FOLATE CA-1515-125 (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)

Other clearances for product code DKP

  • K844167 — ARIA HT PHENOBARBITAL RADIOIMMUNOASSAY KIT (November 27, 1984)
  • K800090 — FLUOROMATIC PHENOLBARBITAL FIA (January 23, 1980)