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FDA 510(k)

QM300 ANTISTREPTOLYSIN O (ASO) ANTIGEN PACK

K-Number: K910886 · 1991-06-17

ApplicantKallestad Diag, A Div. of Erbamont, Inc.
Decision Date1991-06-17
Product CodeGTQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

QM300 ANTISTREPTOLYSIN O (ASO) ANTIGEN PACK is the device name listed in this FDA 510(k) record. The listed applicant is Kallestad Diag, A Div. of Erbamont, Inc.. It received FDA 510(k) clearance on 1991-06-17 under 510(k) number K910886. 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 QM300 ANTISTREPTOLYSIN O (ASO) ANTIGEN PACK?

QM300 ANTISTREPTOLYSIN O (ASO) ANTIGEN PACK is a medical device that received FDA 510(k) clearance on 1991-06-17. The listed applicant is Kallestad Diag, A Div. of Erbamont, Inc.. The 510(k) number is K910886.

When did QM300 ANTISTREPTOLYSIN O (ASO) ANTIGEN PACK receive FDA 510(k) clearance?

QM300 ANTISTREPTOLYSIN O (ASO) ANTIGEN PACK received FDA 510(k) clearance on 1991-06-17, under 510(k) number K910886.

Who is the listed applicant for QM300 ANTISTREPTOLYSIN O (ASO) ANTIGEN PACK?

The FDA 510(k) record lists Kallestad Diag, A Div. of Erbamont, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QM300 ANTISTREPTOLYSIN O (ASO) ANTIGEN PACK?

The FDA product code for QM300 ANTISTREPTOLYSIN O (ASO) ANTIGEN PACK is GTQ.

Related Clinical Trials

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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Other records listing Kallestad Diag, A Div. of Erbamont, 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.

K910885QM300 CALIBRATOR G PACKK910887QM300 CONTROL G PACKK904725CHLAMYDIA SYSTEM SOFTWARE (CSS)K902253PATHFINDER(TM) CHLAMYDIA MICROPLATE KITK902462MODIFIED QM300 RHEUMATOID FACTOR TESTK900010NDS CORTISOL TEST KIT AND NDS CORTISOL CALIBRATOR

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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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