No-Boil Solid Phase Simul Trac B12

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K822721 ↗

FDA Product Code

CDD

Device Class

Class II

Regulation

21 CFR Part 862.1810

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• What is the NO-BOIL SOLID PHASE SIMUL TRAC B12 device used for?

  The device is a radioassay system designed for the measurement of vitamin B12 in clinical specimens. It is a solid phase simulation tracer system used in clinical chemistry laboratories for in vitro diagnostic testing.

• How is the NO-BOIL SOLID PHASE SIMUL TRAC B12 supplied and what is its intended use setting?

  The device is supplied as a reagent kit for in vitro diagnostic use and is intended for use in laboratory settings, specifically clinical chemistry laboratories, to measure vitamin B12 levels in patient specimens.

• What regulatory pathway was used for the NO-BOIL SOLID PHASE SIMUL TRAC B12 and when was it cleared?

  The device received traditional 510(k) clearance from the FDA, with clearance granted on March 10, 1983, under submission number K822721, based on a determination of substantial equivalence.

• What classification and product code apply to the NO-BOIL SOLID PHASE SIMUL TRAC B12 device?

  The device is classified as a Class II medical device with product code CDD and is categorized under the medical specialty of Clinical Chemistry, as indicated in its FDA registration and listing information.