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FDA 510(k)

SMAC REPLACEMENT REAGENTS, WETTING AGENT

K-Number: K800670 · 1980-04-16

ApplicantDiagnostic Solutions, Inc.
Decision Date1980-04-16
Product Code
DecisionSubstantially Equivalent

Device Summary

SMAC REPLACEMENT REAGENTS, WETTING AGENT 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 1980-04-16 under 510(k) number K800670. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMAC REPLACEMENT REAGENTS, WETTING AGENT?

SMAC REPLACEMENT REAGENTS, WETTING AGENT is a medical device that received FDA 510(k) clearance on 1980-04-16. The listed applicant is Diagnostic Solutions, Inc.. The 510(k) number is K800670.

When did SMAC REPLACEMENT REAGENTS, WETTING AGENT receive FDA 510(k) clearance?

SMAC REPLACEMENT REAGENTS, WETTING AGENT received FDA 510(k) clearance on 1980-04-16, under 510(k) number K800670.

Who is the listed applicant for SMAC REPLACEMENT REAGENTS, WETTING AGENT?

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

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Other records listing Diagnostic Solutions, 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.

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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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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