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FDA 510(k)

BILIRUBIN REF., SIGMA STOCK NO. 605-10

K-Number: K760349 · 1976-10-05

ApplicantSigma Chemical Co.
Decision Date1976-10-05
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BILIRUBIN REF., SIGMA STOCK NO. 605-10 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 1976-10-05 under 510(k) number K760349. The device is classified under product code JIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BILIRUBIN REF., SIGMA STOCK NO. 605-10?

BILIRUBIN REF., SIGMA STOCK NO. 605-10 is a medical device that received FDA 510(k) clearance on 1976-10-05. The listed applicant is Sigma Chemical Co.. The 510(k) number is K760349.

When did BILIRUBIN REF., SIGMA STOCK NO. 605-10 receive FDA 510(k) clearance?

BILIRUBIN REF., SIGMA STOCK NO. 605-10 received FDA 510(k) clearance on 1976-10-05, under 510(k) number K760349.

Who is the listed applicant for BILIRUBIN REF., SIGMA STOCK NO. 605-10?

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 BILIRUBIN REF., SIGMA STOCK NO. 605-10?

The FDA product code for BILIRUBIN REF., SIGMA STOCK NO. 605-10 is JIT.

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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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