FDA 510(k)

MALLINCKRODT DIAG. MEDIA WARMER

K-Number: K821401 · 1982-06-17

Decision Date1982-06-17

Product CodeDXT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MALLINCKRODT DIAG. MEDIA WARMER is the device name listed in this FDA 510(k) record. The listed applicant is Forma Scientific, Inc.. It received FDA 510(k) clearance on 1982-06-17 under 510(k) number K821401. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MALLINCKRODT DIAG. MEDIA WARMER?

MALLINCKRODT DIAG. MEDIA WARMER is a medical device that received FDA 510(k) clearance on 1982-06-17. The listed applicant is Forma Scientific, Inc.. The 510(k) number is K821401.

When did MALLINCKRODT DIAG. MEDIA WARMER receive FDA 510(k) clearance?

MALLINCKRODT DIAG. MEDIA WARMER received FDA 510(k) clearance on 1982-06-17, under 510(k) number K821401.

Who is the listed applicant for MALLINCKRODT DIAG. MEDIA WARMER?

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

What is the FDA product code for MALLINCKRODT DIAG. MEDIA WARMER?

The FDA product code for MALLINCKRODT DIAG. MEDIA WARMER is DXT.

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Other records listing Forma Scientific, Inc. as applicant

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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.