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FDA 510(k)

SYNCHRON SYSTEM HEMOGLOBIN ALC REAGENT

K-Number: K973696 · 1997-11-24

ApplicantBeckman Instruments, Inc.
Decision Date1997-11-24
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SYNCHRON SYSTEM HEMOGLOBIN ALC REAGENT 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 1997-11-24 under 510(k) number K973696. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNCHRON SYSTEM HEMOGLOBIN ALC REAGENT?

SYNCHRON SYSTEM HEMOGLOBIN ALC REAGENT is a medical device that received FDA 510(k) clearance on 1997-11-24. The listed applicant is Beckman Instruments, Inc.. The 510(k) number is K973696.

When did SYNCHRON SYSTEM HEMOGLOBIN ALC REAGENT receive FDA 510(k) clearance?

SYNCHRON SYSTEM HEMOGLOBIN ALC REAGENT received FDA 510(k) clearance on 1997-11-24, under 510(k) number K973696.

Who is the listed applicant for SYNCHRON SYSTEM HEMOGLOBIN ALC REAGENT?

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 SYNCHRON SYSTEM HEMOGLOBIN ALC REAGENT?

The FDA product code for SYNCHRON SYSTEM HEMOGLOBIN ALC REAGENT is LCP.

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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: LCP)

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

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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