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FDA 510(k)

SERIMM SURE ASO-CHEK CONTROL SERUM

K-Number: K842839 · 1984-08-23

ApplicantAnalytical Products, Inc.
Decision Date1984-08-23
Product CodeGTQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SERIMM SURE ASO-CHEK CONTROL SERUM 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 1984-08-23 under 510(k) number K842839. 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 SERIMM SURE ASO-CHEK CONTROL SERUM?

SERIMM SURE ASO-CHEK CONTROL SERUM is a medical device that received FDA 510(k) clearance on 1984-08-23. The listed applicant is Analytical Products, Inc.. The 510(k) number is K842839.

When did SERIMM SURE ASO-CHEK CONTROL SERUM receive FDA 510(k) clearance?

SERIMM SURE ASO-CHEK CONTROL SERUM received FDA 510(k) clearance on 1984-08-23, under 510(k) number K842839.

Who is the listed applicant for SERIMM SURE ASO-CHEK CONTROL SERUM?

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 SERIMM SURE ASO-CHEK CONTROL SERUM?

The FDA product code for SERIMM SURE ASO-CHEK CONTROL SERUM is GTQ.

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Other records listing Analytical Products, Inc. as applicant

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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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