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FDA 510(k)

SIGMS B-HYDROXYBUTARATE PROCEDURE NO. 310-UV

K-Number: K850368 · 1985-08-30

ApplicantSigma Chemical Co.
Decision Date1985-08-30
Product CodeJIN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SIGMS B-HYDROXYBUTARATE PROCEDURE NO. 310-UV 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 1985-08-30 under 510(k) number K850368. The device is classified under product code JIN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIGMS B-HYDROXYBUTARATE PROCEDURE NO. 310-UV?

SIGMS B-HYDROXYBUTARATE PROCEDURE NO. 310-UV is a medical device that received FDA 510(k) clearance on 1985-08-30. The listed applicant is Sigma Chemical Co.. The 510(k) number is K850368.

When did SIGMS B-HYDROXYBUTARATE PROCEDURE NO. 310-UV receive FDA 510(k) clearance?

SIGMS B-HYDROXYBUTARATE PROCEDURE NO. 310-UV received FDA 510(k) clearance on 1985-08-30, under 510(k) number K850368.

Who is the listed applicant for SIGMS B-HYDROXYBUTARATE PROCEDURE NO. 310-UV?

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 SIGMS B-HYDROXYBUTARATE PROCEDURE NO. 310-UV?

The FDA product code for SIGMS B-HYDROXYBUTARATE PROCEDURE NO. 310-UV is JIN.

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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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