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FDA 510(k)

BECKMAN SYNCHRON(TM) (MICRO) TOTAL PROTEIN TEST

K-Number: K914885 · 1992-01-30

ApplicantBeckman Instruments, Inc.
Decision Date1992-01-30
Product CodeCEK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BECKMAN SYNCHRON(TM) (MICRO) TOTAL PROTEIN TEST 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 1992-01-30 under 510(k) number K914885. 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 SYNCHRON(TM) (MICRO) TOTAL PROTEIN TEST?

BECKMAN SYNCHRON(TM) (MICRO) TOTAL PROTEIN TEST is a medical device that received FDA 510(k) clearance on 1992-01-30. The listed applicant is Beckman Instruments, Inc.. The 510(k) number is K914885.

When did BECKMAN SYNCHRON(TM) (MICRO) TOTAL PROTEIN TEST receive FDA 510(k) clearance?

BECKMAN SYNCHRON(TM) (MICRO) TOTAL PROTEIN TEST received FDA 510(k) clearance on 1992-01-30, under 510(k) number K914885.

Who is the listed applicant for BECKMAN SYNCHRON(TM) (MICRO) TOTAL PROTEIN TEST?

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 SYNCHRON(TM) (MICRO) TOTAL PROTEIN TEST?

The FDA product code for BECKMAN SYNCHRON(TM) (MICRO) TOTAL PROTEIN TEST is CEK.

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Other records listing Beckman Instruments, Inc. as applicant

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.

K973448ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469K982250ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZERK981403IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENTK981354ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211K980173ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505K974816ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229

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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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