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FDA 510(k)

OPUS B12

K-Number: K953455 · 1995-08-23

ApplicantBehring Diagnostics, Inc.
Decision Date1995-08-23
Product CodeCDD
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OPUS B12 is the device name listed in this FDA 510(k) record. The listed applicant is Behring Diagnostics, Inc.. It received FDA 510(k) clearance on 1995-08-23 under 510(k) number K953455. 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 OPUS B12?

OPUS B12 is a medical device that received FDA 510(k) clearance on 1995-08-23. The listed applicant is Behring Diagnostics, Inc.. The 510(k) number is K953455.

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

OPUS B12 received FDA 510(k) clearance on 1995-08-23, under 510(k) number K953455.

Who is the listed applicant for OPUS B12?

The FDA 510(k) record lists Behring Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPUS B12?

The FDA product code for OPUS B12 is CDD.

Other records listing Behring Diagnostics, Inc. as applicant

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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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