FDA 510(k)

BECKMAN ASTRA SYSTEMS ALBUMIN CHEMISTRY

K-Number: K801750 · 1980-09-16

Decision Date1980-09-16

Product CodeCIX

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

BECKMAN ASTRA SYSTEMS ALBUMIN CHEMISTRY 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 1980-09-16 under 510(k) number K801750. The device is classified under product code CIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BECKMAN ASTRA SYSTEMS ALBUMIN CHEMISTRY?

BECKMAN ASTRA SYSTEMS ALBUMIN CHEMISTRY is a medical device that received FDA 510(k) clearance on 1980-09-16. The listed applicant is Beckman Instruments, Inc.. The 510(k) number is K801750.

When did BECKMAN ASTRA SYSTEMS ALBUMIN CHEMISTRY receive FDA 510(k) clearance?

BECKMAN ASTRA SYSTEMS ALBUMIN CHEMISTRY received FDA 510(k) clearance on 1980-09-16, under 510(k) number K801750.

Who is the listed applicant for BECKMAN ASTRA SYSTEMS ALBUMIN CHEMISTRY?

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 SYSTEMS ALBUMIN CHEMISTRY?

The FDA product code for BECKMAN ASTRA SYSTEMS ALBUMIN CHEMISTRY is CIX.

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Other records listing Beckman Instruments, Inc. as applicant

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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.