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FDA 510(k)

TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROL

K-Number: K922723 · 1992-09-18

ApplicantSimplicity Diagnostics, Inc.
Decision Date1992-09-18
Product CodeGTQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Simplicity Diagnostics, Inc.. It received FDA 510(k) clearance on 1992-09-18 under 510(k) number K922723. 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 TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROL?

TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROL is a medical device that received FDA 510(k) clearance on 1992-09-18. The listed applicant is Simplicity Diagnostics, Inc.. The 510(k) number is K922723.

When did TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROL receive FDA 510(k) clearance?

TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROL received FDA 510(k) clearance on 1992-09-18, under 510(k) number K922723.

Who is the listed applicant for TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROL?

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

What is the FDA product code for TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROL?

The FDA product code for TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROL 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 Simplicity Diagnostics, 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.

K970100TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROLK922726TECH SIMPLE INFECTIOUS MONONUCLEOSIS SERUM CONTROLK922722TECH DIMPLE C-REACTIVE PROTEIN SERUM CONTROLK922725TECH SIMPLE RHEUMATOID FACTOR SERUM CONTROL

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.K915053BECKMAN ANTISTREPTOLYSIN O, MODIFICATIONBeckman Instruments, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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