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FDA 510(k)

BECKMAN ASTRA SYSTEMS TOTAL PROTEIN CHEM

K-Number: K801749 · 1980-09-16

ApplicantBeckman Instruments, Inc.
Decision Date1980-09-16
Product CodeCEK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BECKMAN ASTRA SYSTEMS TOTAL PROTEIN CHEM 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 K801749. The device is classified under product code CEK. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BECKMAN ASTRA SYSTEMS TOTAL PROTEIN CHEM?

BECKMAN ASTRA SYSTEMS TOTAL PROTEIN CHEM 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 K801749.

When did BECKMAN ASTRA SYSTEMS TOTAL PROTEIN CHEM receive FDA 510(k) clearance?

BECKMAN ASTRA SYSTEMS TOTAL PROTEIN CHEM received FDA 510(k) clearance on 1980-09-16, under 510(k) number K801749.

Who is the listed applicant for BECKMAN ASTRA SYSTEMS TOTAL PROTEIN CHEM?

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 TOTAL PROTEIN CHEM?

The FDA product code for BECKMAN ASTRA SYSTEMS TOTAL PROTEIN CHEM is CEK.

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Other records listing Beckman Instruments, Inc. as applicant

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Related Devices (Code: CEK)

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.

K992846HICHEM TOTAL PROTEIN REAGENTElan Holdings, Inc.K973108TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50Diagnostic Chemicals , Ltd.K980042CARESIDE TOTAL PROTEINExigent Diagnostics, Inc.K971524TOTAL PROTEIN OR TPCarolina Liquid Chemistries Corp.K961864CSF/URINE TOTAL PROTEINTeco DiagnosticsK955905STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAYSolarcare Technologies Corp,Inc.

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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