FDA 510(k)

SPIN CHEM REAGENT, DETERMINATION OF AST

K-Number: K791082 · 1979-07-17

Decision Date1979-07-17

Product CodeCIT

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

SPIN CHEM REAGENT, DETERMINATION OF AST is the device name listed in this FDA 510(k) record. The listed applicant is Smithkline Diagnostics, Inc.. It received FDA 510(k) clearance on 1979-07-17 under 510(k) number K791082. 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 SPIN CHEM REAGENT, DETERMINATION OF AST?

SPIN CHEM REAGENT, DETERMINATION OF AST is a medical device that received FDA 510(k) clearance on 1979-07-17. The listed applicant is Smithkline Diagnostics, Inc.. The 510(k) number is K791082.

When did SPIN CHEM REAGENT, DETERMINATION OF AST receive FDA 510(k) clearance?

SPIN CHEM REAGENT, DETERMINATION OF AST received FDA 510(k) clearance on 1979-07-17, under 510(k) number K791082.

Who is the listed applicant for SPIN CHEM REAGENT, DETERMINATION OF AST?

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

What is the FDA product code for SPIN CHEM REAGENT, DETERMINATION OF AST?

The FDA product code for SPIN CHEM REAGENT, DETERMINATION OF AST is CIT.

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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.