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FDA 510(k)

SMAC REPLACEMENT REAGENTS/DETERM-URIC-AC

K-Number: K800672 · 1980-05-28

ApplicantDiagnostic Solutions, Inc.
Decision Date1980-05-28
Product CodeCDH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SMAC REPLACEMENT REAGENTS/DETERM-URIC-AC is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Solutions, Inc.. It received FDA 510(k) clearance on 1980-05-28 under 510(k) number K800672. The device is classified under product code CDH. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMAC REPLACEMENT REAGENTS/DETERM-URIC-AC?

SMAC REPLACEMENT REAGENTS/DETERM-URIC-AC is a medical device that received FDA 510(k) clearance on 1980-05-28. The listed applicant is Diagnostic Solutions, Inc.. The 510(k) number is K800672.

When did SMAC REPLACEMENT REAGENTS/DETERM-URIC-AC receive FDA 510(k) clearance?

SMAC REPLACEMENT REAGENTS/DETERM-URIC-AC received FDA 510(k) clearance on 1980-05-28, under 510(k) number K800672.

Who is the listed applicant for SMAC REPLACEMENT REAGENTS/DETERM-URIC-AC?

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

What is the FDA product code for SMAC REPLACEMENT REAGENTS/DETERM-URIC-AC?

The FDA product code for SMAC REPLACEMENT REAGENTS/DETERM-URIC-AC is CDH.

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Other records listing Diagnostic Solutions, Inc. as applicant

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K934892RELIEF PLUS ONE REAGENT STRIP MODIFICATIONK924398UNI-CHECK REAGENT STRIPK921825QUICK-CHECK II REAGENT STRIPK800689REAGENT FOR DETERM. GLUTAMIC-PYRUVIC-K800681REAGENTS FOR DETERM. CO2 IN HUMAN SERUMK800691REAGENT FOR DETERM. LACTATE/DEHYDROGENAS

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Related Devices (Code: CDH)

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.

K850933URIC ACIDDilab, Inc.K841067URIC ACID REAGENT SETMedical Specialties, Inc.K821213URIC ACID REAGENT SETOmega Medical ElectronicsK813076PHOSPHOTUNGSTATE REDUCTION, URIC ACIDAmerican Monitor Corp.K810088URIC ACID (TPTZ) COLORINMETRICBio-Analytics Laboratories, Inc.K800190STANBIO DIRECT URIC ACID TEST SET #0770Stanbio Laboratory

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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