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FDA 510(k)

QUANTEX ASO PLUS (LATEX,BUFFER STANDARD,CONTROL)

K-Number: K894486 · 1989-10-24

ApplicantBiokit USA, Inc.
Decision Date1989-10-24
Product CodeGTQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

QUANTEX ASO PLUS (LATEX,BUFFER STANDARD,CONTROL) is the device name listed in this FDA 510(k) record. The listed applicant is Biokit USA, Inc.. It received FDA 510(k) clearance on 1989-10-24 under 510(k) number K894486. 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 QUANTEX ASO PLUS (LATEX,BUFFER STANDARD,CONTROL)?

QUANTEX ASO PLUS (LATEX,BUFFER STANDARD,CONTROL) is a medical device that received FDA 510(k) clearance on 1989-10-24. The listed applicant is Biokit USA, Inc.. The 510(k) number is K894486.

When did QUANTEX ASO PLUS (LATEX,BUFFER STANDARD,CONTROL) receive FDA 510(k) clearance?

QUANTEX ASO PLUS (LATEX,BUFFER STANDARD,CONTROL) received FDA 510(k) clearance on 1989-10-24, under 510(k) number K894486.

Who is the listed applicant for QUANTEX ASO PLUS (LATEX,BUFFER STANDARD,CONTROL)?

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

What is the FDA product code for QUANTEX ASO PLUS (LATEX,BUFFER STANDARD,CONTROL)?

The FDA product code for QUANTEX ASO PLUS (LATEX,BUFFER STANDARD,CONTROL) is GTQ.

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Other records listing Biokit USA, 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.

K913467TOXOGENK910541BIOKIT RPRK904310RHEUMAGEN RF T-CONTROLK910539RHEUMAJET RFK910686RHEUMAJET CRPK904311RHEUMAGEN ASO T-CONTROL

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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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