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FDA 510(k)

ULTRACHEM CREA #64972

K-Number: K821472 · 1982-06-03

ApplicantEmd Chemicals, Inc.
Decision Date1982-06-03
Product Code
DecisionSubstantially Equivalent

Device Summary

ULTRACHEM CREA #64972 is the device name listed in this FDA 510(k) record. The listed applicant is Emd Chemicals, Inc.. It received FDA 510(k) clearance on 1982-06-03 under 510(k) number K821472. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRACHEM CREA #64972?

ULTRACHEM CREA #64972 is a medical device that received FDA 510(k) clearance on 1982-06-03. The listed applicant is Emd Chemicals, Inc.. The 510(k) number is K821472.

When did ULTRACHEM CREA #64972 receive FDA 510(k) clearance?

ULTRACHEM CREA #64972 received FDA 510(k) clearance on 1982-06-03, under 510(k) number K821472.

Who is the listed applicant for ULTRACHEM CREA #64972?

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

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Other records listing Emd Chemicals, 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.

K031367DUOPATH VEROTOXINS GLISA TESTK990516ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONSK981926ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONSK973054ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONSK951494AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR)K951750GLUCOSE TEST ITEM NUMBER 97375/94

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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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