FDA 510(k)

UNISTAT BILIRUBINOMETER

K-Number: K781241 · 1978-08-14

Decision Date1978-08-14

Product CodeJJQ

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

UNISTAT BILIRUBINOMETER is the device name listed in this FDA 510(k) record. The listed applicant is American Optical Corp.. It received FDA 510(k) clearance on 1978-08-14 under 510(k) number K781241. The device is classified under product code JJQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNISTAT BILIRUBINOMETER?

UNISTAT BILIRUBINOMETER is a medical device that received FDA 510(k) clearance on 1978-08-14. The listed applicant is American Optical Corp.. The 510(k) number is K781241.

When did UNISTAT BILIRUBINOMETER receive FDA 510(k) clearance?

UNISTAT BILIRUBINOMETER received FDA 510(k) clearance on 1978-08-14, under 510(k) number K781241.

Who is the listed applicant for UNISTAT BILIRUBINOMETER?

The FDA 510(k) record lists American Optical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNISTAT BILIRUBINOMETER?

The FDA product code for UNISTAT BILIRUBINOMETER is JJQ.

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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.