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FDA 510(k)

BECKMAN ANTISTREPTOLYSIN O, MODIFICATION

K-Number: K915053 · 1992-03-19

ApplicantBeckman Instruments, Inc.
Decision Date1992-03-19
Product CodeGTQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BECKMAN ANTISTREPTOLYSIN O, MODIFICATION 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 1992-03-19 under 510(k) number K915053. 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 ANTISTREPTOLYSIN O, MODIFICATION?

BECKMAN ANTISTREPTOLYSIN O, MODIFICATION is a medical device that received FDA 510(k) clearance on 1992-03-19. The listed applicant is Beckman Instruments, Inc.. The 510(k) number is K915053.

When did BECKMAN ANTISTREPTOLYSIN O, MODIFICATION receive FDA 510(k) clearance?

BECKMAN ANTISTREPTOLYSIN O, MODIFICATION received FDA 510(k) clearance on 1992-03-19, under 510(k) number K915053.

Who is the listed applicant for BECKMAN ANTISTREPTOLYSIN O, MODIFICATION?

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 ANTISTREPTOLYSIN O, MODIFICATION?

The FDA product code for BECKMAN ANTISTREPTOLYSIN O, MODIFICATION 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.

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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.K926236BECKMAN ANTI-STREPTOLYSIN O KITBeckman Instruments, Inc.K924247ACCUTEX ASO LATEX TESTJ.S. Medical Assoc.K922723TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROLSimplicity Diagnostics, 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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