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FDA 510(k)

CYTOMEGELISA TEST KIT

K-Number: K812123 · 1981-09-23

Decision Date1981-09-23
Product Code
DecisionSubstantially Equivalent

Device Summary

CYTOMEGELISA TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is M.A. Bioproducts. It received FDA 510(k) clearance on 1981-09-23 under 510(k) number K812123. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CYTOMEGELISA TEST KIT?

CYTOMEGELISA TEST KIT is a medical device that received FDA 510(k) clearance on 1981-09-23. The listed applicant is M.A. Bioproducts. The 510(k) number is K812123.

When did CYTOMEGELISA TEST KIT receive FDA 510(k) clearance?

CYTOMEGELISA TEST KIT received FDA 510(k) clearance on 1981-09-23, under 510(k) number K812123.

Who is the listed applicant for CYTOMEGELISA TEST KIT?

The FDA 510(k) record lists M.A. Bioproducts as the applicant. This does not by itself establish the device manufacturer.

Related Clinical Trials

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.

Other records listing M.A. Bioproducts as applicant

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.

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Official Source

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

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