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510(k) K832710

VITAMIN B12 RADIOASSAY KIT CA-1534 by Clinical Assays, Inc. — Product Code CDD

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
Radioassay, Vitamin B12
Device Class
Class II
Regulation Number
862.1810
Review Panel
CH
Submission Type

Other clearances by Clinical Assays, Inc.

  • K832711 — VITAMIN B12 FOLATE CA-1515-125 (October 4, 1983)
  • K832712 — FOLATE RADIOASSAY KIT CA-1562-125 (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)
  • K801667 — GAMMA COAT(125 I) RUBELLA ANTIBODY (October 23, 1980)

Other clearances for product code CDD

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  • K192064 — LIAISON Vitamin B12 (October 2, 2019)
  • K172133 — ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay (October 27, 2017)
  • K161721 — Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin (September 20, 2016)
  • K160757 — ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active- (July 26, 2016)
  • K151786 — Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet (September 24, 2015)
  • K140496 — Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYP (September 16, 2014)
  • K133512 — LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM CAL (January 2, 2014)