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FDA 510(k)

ASO QUANTUM, ANTISTREPTOLYSIN O TEST

K-Number: K801177 · 1980-07-08

ApplicantSclavo, Inc.
Decision Date1980-07-08
Product CodeGTQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ASO QUANTUM, ANTISTREPTOLYSIN O TEST is the device name listed in this FDA 510(k) record. The listed applicant is Sclavo, Inc.. It received FDA 510(k) clearance on 1980-07-08 under 510(k) number K801177. 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 ASO QUANTUM, ANTISTREPTOLYSIN O TEST?

ASO QUANTUM, ANTISTREPTOLYSIN O TEST is a medical device that received FDA 510(k) clearance on 1980-07-08. The listed applicant is Sclavo, Inc.. The 510(k) number is K801177.

When did ASO QUANTUM, ANTISTREPTOLYSIN O TEST receive FDA 510(k) clearance?

ASO QUANTUM, ANTISTREPTOLYSIN O TEST received FDA 510(k) clearance on 1980-07-08, under 510(k) number K801177.

Who is the listed applicant for ASO QUANTUM, ANTISTREPTOLYSIN O TEST?

The FDA 510(k) record lists Sclavo, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ASO QUANTUM, ANTISTREPTOLYSIN O TEST?

The FDA product code for ASO QUANTUM, ANTISTREPTOLYSIN O TEST is GTQ.

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Other records listing Sclavo, 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.

K914789ELISA CMV IGMK914852ELISA TOXO IGMK914420ELISA RUBELLA IGMK895943NORMAL AND ABNORMAL CONTROL SERAK895822TOTAL BILIRUBIN L.F.K895847CREATININE 340 (ENZYMATIC)

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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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