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FDA 510(k)

IMMUNOCHEMISTRY SYSTEM BETA-2-MICROGLOBULIN REAGENT

K-Number: K973813 · 1997-11-20

ApplicantBeckman Instruments, Inc.
Decision Date1997-11-20
Product CodeJZG
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMMUNOCHEMISTRY SYSTEM BETA-2-MICROGLOBULIN 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 1997-11-20 under 510(k) number K973813. The device is classified under product code JZG. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMUNOCHEMISTRY SYSTEM BETA-2-MICROGLOBULIN REAGENT?

IMMUNOCHEMISTRY SYSTEM BETA-2-MICROGLOBULIN REAGENT is a medical device that received FDA 510(k) clearance on 1997-11-20. The listed applicant is Beckman Instruments, Inc.. The 510(k) number is K973813.

When did IMMUNOCHEMISTRY SYSTEM BETA-2-MICROGLOBULIN REAGENT receive FDA 510(k) clearance?

IMMUNOCHEMISTRY SYSTEM BETA-2-MICROGLOBULIN REAGENT received FDA 510(k) clearance on 1997-11-20, under 510(k) number K973813.

Who is the listed applicant for IMMUNOCHEMISTRY SYSTEM BETA-2-MICROGLOBULIN 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 IMMUNOCHEMISTRY SYSTEM BETA-2-MICROGLOBULIN REAGENT?

The FDA product code for IMMUNOCHEMISTRY SYSTEM BETA-2-MICROGLOBULIN REAGENT is JZG.

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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

View all 281 devices →

Related Devices (Code: JZG)

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.

K161297Beta-2-MicroglobulinBeckman Coulter Ireland, Inc.K122066HUMAN BETA-2 MICROGLOBULIN URINE KIT FOR USE ON THE SPAPLUSThe Binding Site Group , Ltd.K110874ADVIA CHEMISTRY REAGENTS, AND ADVIA CHEMISTRY B2-MICROGLOBULIN CALIBRATORSiemens Healthcare Diagnostics, Inc.K083289HUMAN BETA-2 MICROGLOBULIN KITThe Binding Site, Ltd.K083463DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIMENSION VISTA PROTEIN 1 CONTROL MSiemens Healthcare DiagnosticsK072078QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307Biokit, S.A.

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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