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FDA 510(k)

BECKMAN ANTI-STREPTOLYSIN O KIT

K-Number: K926236 · 1993-06-15

ApplicantBeckman Instruments, Inc.
Decision Date1993-06-15
Product CodeGTQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BECKMAN ANTI-STREPTOLYSIN O KIT 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 1993-06-15 under 510(k) number K926236. The device is classified under product code GTQ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BECKMAN ANTI-STREPTOLYSIN O KIT?

BECKMAN ANTI-STREPTOLYSIN O KIT is a medical device that received FDA 510(k) clearance on 1993-06-15. The listed applicant is Beckman Instruments, Inc.. The 510(k) number is K926236.

When did BECKMAN ANTI-STREPTOLYSIN O KIT receive FDA 510(k) clearance?

BECKMAN ANTI-STREPTOLYSIN O KIT received FDA 510(k) clearance on 1993-06-15, under 510(k) number K926236.

Who is the listed applicant for BECKMAN ANTI-STREPTOLYSIN O KIT?

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 ANTI-STREPTOLYSIN O KIT?

The FDA product code for BECKMAN ANTI-STREPTOLYSIN O KIT is GTQ.

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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: GTQ)

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.

K052645VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PRODUCTS FS CALIBRATOR 1, REF 6801873;Ortho-Clinical DiagnosticsK953437OLYMPUS ANTI-STERPTOLYSIN O IMMUNOTURBIDIMETRIC REAGENTOlympus America, Inc.K915742TURBIQUANT ASLBehring Diagnostics, Inc.K924247ACCUTEX ASO LATEX TESTJ.S. Medical Assoc.K922723TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROLSimplicity Diagnostics, Inc.K915053BECKMAN ANTISTREPTOLYSIN O, MODIFICATIONBeckman Instruments, 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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