FDA 510(k)

AST REAGENT (PROCEDURE NUMBER 158)

K-Number: K892844 · 1989-06-20

Decision Date1989-06-20

Product CodeCIT

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

AST REAGENT (PROCEDURE NUMBER 158) is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Chemical Co.. It received FDA 510(k) clearance on 1989-06-20 under 510(k) number K892844. 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 AST REAGENT (PROCEDURE NUMBER 158)?

AST REAGENT (PROCEDURE NUMBER 158) is a medical device that received FDA 510(k) clearance on 1989-06-20. The listed applicant is Sigma Chemical Co.. The 510(k) number is K892844.

When did AST REAGENT (PROCEDURE NUMBER 158) receive FDA 510(k) clearance?

AST REAGENT (PROCEDURE NUMBER 158) received FDA 510(k) clearance on 1989-06-20, under 510(k) number K892844.

Who is the listed applicant for AST REAGENT (PROCEDURE NUMBER 158)?

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

What is the FDA product code for AST REAGENT (PROCEDURE NUMBER 158)?

The FDA product code for AST REAGENT (PROCEDURE NUMBER 158) is CIT.

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Related Devices (Code: 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.