FDA 510(k)

SIGMA DIAGNOSTICS INFINITY ASTBUN REAGENT, MODEL 51-25, SIGMA DIAGNOSTICS INFINITY AST REAGENT, MODELS 51-100P,51-500P,5

K-Number: K992801 · 1999-09-28

Decision Date1999-09-28

Product CodeCIT

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

SIGMA DIAGNOSTICS INFINITY ASTBUN REAGENT, MODEL 51-25, SIGMA DIAGNOSTICS INFINITY AST REAGENT, MODELS 51-100P,51-500P,5 is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Diagnostics, Inc.. It received FDA 510(k) clearance on 1999-09-28 under 510(k) number K992801. The device is classified under product code CIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIGMA DIAGNOSTICS INFINITY ASTBUN REAGENT, MODEL 51-25, SIGMA DIAGNOSTICS INFINITY AST REAGENT, MODELS 51-100P,51-500P,5?

SIGMA DIAGNOSTICS INFINITY ASTBUN REAGENT, MODEL 51-25, SIGMA DIAGNOSTICS INFINITY AST REAGENT, MODELS 51-100P,51-500P,5 is a medical device that received FDA 510(k) clearance on 1999-09-28. The listed applicant is Sigma Diagnostics, Inc.. The 510(k) number is K992801.

When did SIGMA DIAGNOSTICS INFINITY ASTBUN REAGENT, MODEL 51-25, SIGMA DIAGNOSTICS INFINITY AST REAGENT, MODELS 51-100P,51-500P,5 receive FDA 510(k) clearance?

SIGMA DIAGNOSTICS INFINITY ASTBUN REAGENT, MODEL 51-25, SIGMA DIAGNOSTICS INFINITY AST REAGENT, MODELS 51-100P,51-500P,5 received FDA 510(k) clearance on 1999-09-28, under 510(k) number K992801.

Who is the listed applicant for SIGMA DIAGNOSTICS INFINITY ASTBUN REAGENT, MODEL 51-25, SIGMA DIAGNOSTICS INFINITY AST REAGENT, MODELS 51-100P,51-500P,5?

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

What is the FDA product code for SIGMA DIAGNOSTICS INFINITY ASTBUN REAGENT, MODEL 51-25, SIGMA DIAGNOSTICS INFINITY AST REAGENT, MODELS 51-100P,51-500P,5?

The FDA product code for SIGMA DIAGNOSTICS INFINITY ASTBUN REAGENT, MODEL 51-25, SIGMA DIAGNOSTICS INFINITY AST REAGENT, MODELS 51-100P,51-500P,5 is CIT.

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Other records listing Sigma Diagnostics, Inc. as applicant

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Official Source

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