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FDA 510(k)

ULTRAZYME PLUS LDH, #64950,65038&65039

K-Number: K821466 · 1982-06-01

ApplicantEmd Chemicals, Inc.
Decision Date1982-06-01
Product CodeCFJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ULTRAZYME PLUS LDH, #64950,65038&65039 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 1982-06-01 under 510(k) number K821466. The device is classified under product code CFJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRAZYME PLUS LDH, #64950,65038&65039?

ULTRAZYME PLUS LDH, #64950,65038&65039 is a medical device that received FDA 510(k) clearance on 1982-06-01. The listed applicant is Emd Chemicals, Inc.. The 510(k) number is K821466.

When did ULTRAZYME PLUS LDH, #64950,65038&65039 receive FDA 510(k) clearance?

ULTRAZYME PLUS LDH, #64950,65038&65039 received FDA 510(k) clearance on 1982-06-01, under 510(k) number K821466.

Who is the listed applicant for ULTRAZYME PLUS LDH, #64950,65038&65039?

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 ULTRAZYME PLUS LDH, #64950,65038&65039?

The FDA product code for ULTRAZYME PLUS LDH, #64950,65038&65039 is CFJ.

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Other records listing Emd Chemicals, Inc. as applicant

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Related Devices (Code: CFJ)

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.

K131975ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENTAlfa Wassermann Diagnostic Technologies, Inc.K091544S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017Alfa Wassermann, Inc.K051108PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEMAbaxis, Inc.K974859LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30Diagnostic Chemicals , Ltd.K973589LIQUID LDH-L REAGENT SETPointe Scientific, Inc.,K970684LACTATE DEHYDROGENASE (LD)Randox Laboratories, Ltd.

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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