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FDA 510(k)

CREATININE STANDARD #65072

K-Number: K822477 · 1982-09-17

ApplicantEmd Chemicals, Inc.
Decision Date1982-09-17
Product CodeJIS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CREATININE STANDARD #65072 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 1982-09-17 under 510(k) number K822477. The device is classified under product code JIS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CREATININE STANDARD #65072?

CREATININE STANDARD #65072 is a medical device that received FDA 510(k) clearance on 1982-09-17. The listed applicant is Emd Chemicals, Inc.. The 510(k) number is K822477.

When did CREATININE STANDARD #65072 receive FDA 510(k) clearance?

CREATININE STANDARD #65072 received FDA 510(k) clearance on 1982-09-17, under 510(k) number K822477.

Who is the listed applicant for CREATININE STANDARD #65072?

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

What is the FDA product code for CREATININE STANDARD #65072?

The FDA product code for CREATININE STANDARD #65072 is JIS.

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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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Related Devices (Code: JIS)

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

View on FDA Database →

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

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