FDA 510(k)

MCD-AC

K-Number: K971980 · 1997-10-23

Decision Date1997-10-23

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

MCD-AC is the device name listed in this FDA 510(k) record. The listed applicant is Adac Laboratories. It received FDA 510(k) clearance on 1997-10-23 under 510(k) number K971980. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MCD-AC?

MCD-AC is a medical device that received FDA 510(k) clearance on 1997-10-23. The listed applicant is Adac Laboratories. The 510(k) number is K971980.

When did MCD-AC receive FDA 510(k) clearance?

MCD-AC received FDA 510(k) clearance on 1997-10-23, under 510(k) number K971980.

Who is the listed applicant for MCD-AC?

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

What is the FDA product code for MCD-AC?

The FDA product code for MCD-AC is KPS.

Other records listing Adac Laboratories 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.

K062298APOLLO GAMMA CAMERA SYSTEM K061029JETSTREAM WORKSPACE K060020AUTOQUANT PLUS K051351PRECEDENCE SPECT/CT IMAGING SYSTEM K042880JETSTREAM WORKSPACE K042903AUTOSPECS

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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.