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FDA 510(k)

ULTRACHEM URIC ACID AIDH, #65047

K-Number: K821465 · 1982-06-02

ApplicantEmd Chemicals, Inc.
Decision Date1982-06-02
Product CodeCDO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ULTRACHEM URIC ACID AIDH, #65047 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 1982-06-02 under 510(k) number K821465. The device is classified under product code CDO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRACHEM URIC ACID AIDH, #65047?

ULTRACHEM URIC ACID AIDH, #65047 is a medical device that received FDA 510(k) clearance on 1982-06-02. The listed applicant is Emd Chemicals, Inc.. The 510(k) number is K821465.

When did ULTRACHEM URIC ACID AIDH, #65047 receive FDA 510(k) clearance?

ULTRACHEM URIC ACID AIDH, #65047 received FDA 510(k) clearance on 1982-06-02, under 510(k) number K821465.

Who is the listed applicant for ULTRACHEM URIC ACID AIDH, #65047?

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 ULTRACHEM URIC ACID AIDH, #65047?

The FDA product code for ULTRACHEM URIC ACID AIDH, #65047 is CDO.

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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: CDO)

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.

K033278RANDOX URIC ACIDRandox Laboratories, Ltd.K992798SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P, 684-500P, 684-2000P, 683-20, 683-100PSigma Diagnostics, Inc.K982251SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KITSigma Diagnostics, Inc.K981766URIC ACIDAbbott LaboratoriesK981189URIC ACIDAbbott LaboratoriesK971485URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)Trace America, Inc.

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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