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FDA 510(k)

AFFINITY B12

K-Number: K920078 · 1992-02-14

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1992-02-14
Product CodeCDD
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AFFINITY B12 is the device name listed in this FDA 510(k) record. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. It received FDA 510(k) clearance on 1992-02-14 under 510(k) number K920078. The device is classified under product code CDD. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AFFINITY B12?

AFFINITY B12 is a medical device that received FDA 510(k) clearance on 1992-02-14. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K920078.

When did AFFINITY B12 receive FDA 510(k) clearance?

AFFINITY B12 received FDA 510(k) clearance on 1992-02-14, under 510(k) number K920078.

Who is the listed applicant for AFFINITY B12?

The FDA 510(k) record lists Bd Becton Dickinson Vacutainer Systems Preanalytic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AFFINITY B12?

The FDA product code for AFFINITY B12 is CDD.

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Related Devices (Code: CDD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233541ARCHITECT Active-B12 (Holotranscobalamin)Axis-Shield Diagnostics, Ltd.K223289Access Vitamin B12Beckman Coulter, Inc.K190298DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12Beckman Coulter Biomedical GmbHK192064LIAISON Vitamin B12DiaSorin, Inc.K172133ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) AssayAxis-Shield Diagnostics, Ltd.K161721Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls SetDiazyme Laboratories

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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