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510(k) K760619

RADIO IMMUNO ASSAY KIT/ by New England Nuclear — Product Code CDD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 1976
Date Received
September 13, 1976
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 New England Nuclear

  • K841478 — RIANEN CYCLIC-AMP RADIOIMMUNOASSAY (June 14, 1984)
  • K840301 — RIANEN ESTRIOL RADIOIMMUNOASSAY KIT (March 30, 1984)
  • K834038 — RIANEN FOLLICLE STIMULATING HORMONE (January 30, 1984)
  • K833376 — RIANEN LUTEINIZING HORMONE RIA KIT (December 20, 1983)
  • K831345 — RIANEN PROLACTIN 125I KIT (June 8, 1983)
  • K801245 — ATOMLIGHT (LIQUID SCINTILLATION SOLUTION (June 20, 1980)
  • K792175 — RIANEN, VITAMIN B12 ASSAY SYSTEM (November 13, 1979)
  • K790817 — RIA KIT, QUANTITATION OF PROSTATIC ACID (May 7, 1979)
  • K782110 — RIA KIT, RIANEN CORTISOL (January 26, 1979)
  • K781888 — ASSAY SYSTEM, FERRITIN I KIT (January 10, 1979)

Other clearances for product code CDD

  • K233541 — ARCHITECT Active-B12 (Holotranscobalamin) (July 31, 2024)
  • K223289 — Access Vitamin B12 (December 23, 2022)
  • K190298 — DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Acc (October 4, 2019)
  • 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)