FDA 510(k)

NML CK-MB RIA

K-Number: K812759 · 1981-10-19

ApplicantNuclear Medical Laboratories, Inc.

Decision Date1981-10-19

Product CodeJHX

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

NML CK-MB RIA is the device name listed in this FDA 510(k) record. The listed applicant is Nuclear Medical Laboratories, Inc.. It received FDA 510(k) clearance on 1981-10-19 under 510(k) number K812759. The device is classified under product code JHX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NML CK-MB RIA?

NML CK-MB RIA is a medical device that received FDA 510(k) clearance on 1981-10-19. The listed applicant is Nuclear Medical Laboratories, Inc.. The 510(k) number is K812759.

When did NML CK-MB RIA receive FDA 510(k) clearance?

NML CK-MB RIA received FDA 510(k) clearance on 1981-10-19, under 510(k) number K812759.

Who is the listed applicant for NML CK-MB RIA?

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

What is the FDA product code for NML CK-MB RIA?

The FDA product code for NML CK-MB RIA is JHX.

Other records listing Nuclear Medical Laboratories, Inc. 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.