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FDA 510(k)

ASO SURE

K-Number: K820785 · 1982-04-08

ApplicantAnalytical Products, Inc.
Decision Date1982-04-08
Product CodeGTQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ASO SURE is the device name listed in this FDA 510(k) record. The listed applicant is Analytical Products, Inc.. It received FDA 510(k) clearance on 1982-04-08 under 510(k) number K820785. 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 SURE?

ASO SURE is a medical device that received FDA 510(k) clearance on 1982-04-08. The listed applicant is Analytical Products, Inc.. The 510(k) number is K820785.

When did ASO SURE receive FDA 510(k) clearance?

ASO SURE received FDA 510(k) clearance on 1982-04-08, under 510(k) number K820785.

Who is the listed applicant for ASO SURE?

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

What is the FDA product code for ASO SURE?

The FDA product code for ASO SURE is GTQ.

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Related Devices (Code: GTQ)

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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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