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FDA 510(k)

ULTIMATE DIRECT & TOTAL BILIRUBIN CONTRO

K-Number: K802068 · 1980-10-10

ApplicantBeckman Instruments, Inc.
Decision Date1980-10-10
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ULTIMATE DIRECT & TOTAL BILIRUBIN CONTRO is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Instruments, Inc.. It received FDA 510(k) clearance on 1980-10-10 under 510(k) number K802068. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTIMATE DIRECT & TOTAL BILIRUBIN CONTRO?

ULTIMATE DIRECT & TOTAL BILIRUBIN CONTRO is a medical device that received FDA 510(k) clearance on 1980-10-10. The listed applicant is Beckman Instruments, Inc.. The 510(k) number is K802068.

When did ULTIMATE DIRECT & TOTAL BILIRUBIN CONTRO receive FDA 510(k) clearance?

ULTIMATE DIRECT & TOTAL BILIRUBIN CONTRO received FDA 510(k) clearance on 1980-10-10, under 510(k) number K802068.

Who is the listed applicant for ULTIMATE DIRECT & TOTAL BILIRUBIN CONTRO?

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

What is the FDA product code for ULTIMATE DIRECT & TOTAL BILIRUBIN CONTRO?

The FDA product code for ULTIMATE DIRECT & TOTAL BILIRUBIN CONTRO is JJX.

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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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