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FDA 510(k)

BECKMAN ASTRA SYS. TOTAL BILIRUBIN MOD

K-Number: K812784 · 1981-10-20

ApplicantBeckman Instruments, Inc.
Decision Date1981-10-20
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BECKMAN ASTRA SYS. TOTAL BILIRUBIN MOD 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 1981-10-20 under 510(k) number K812784. The device is classified under product code CIG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BECKMAN ASTRA SYS. TOTAL BILIRUBIN MOD?

BECKMAN ASTRA SYS. TOTAL BILIRUBIN MOD is a medical device that received FDA 510(k) clearance on 1981-10-20. The listed applicant is Beckman Instruments, Inc.. The 510(k) number is K812784.

When did BECKMAN ASTRA SYS. TOTAL BILIRUBIN MOD receive FDA 510(k) clearance?

BECKMAN ASTRA SYS. TOTAL BILIRUBIN MOD received FDA 510(k) clearance on 1981-10-20, under 510(k) number K812784.

Who is the listed applicant for BECKMAN ASTRA SYS. TOTAL BILIRUBIN MOD?

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 BECKMAN ASTRA SYS. TOTAL BILIRUBIN MOD?

The FDA product code for BECKMAN ASTRA SYS. TOTAL BILIRUBIN MOD is CIG.

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Other records listing Beckman Instruments, Inc. as applicant

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Related Devices (Code: CIG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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