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FDA 510(k)

RAPITEX(R) ASL NEW

K-Number: K903854 · 1991-01-28

ApplicantBehring Diagnostics, Inc.
Decision Date1991-01-28
Product CodeGTQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RAPITEX(R) ASL NEW is the device name listed in this FDA 510(k) record. The listed applicant is Behring Diagnostics, Inc.. It received FDA 510(k) clearance on 1991-01-28 under 510(k) number K903854. 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 RAPITEX(R) ASL NEW?

RAPITEX(R) ASL NEW is a medical device that received FDA 510(k) clearance on 1991-01-28. The listed applicant is Behring Diagnostics, Inc.. The 510(k) number is K903854.

When did RAPITEX(R) ASL NEW receive FDA 510(k) clearance?

RAPITEX(R) ASL NEW received FDA 510(k) clearance on 1991-01-28, under 510(k) number K903854.

Who is the listed applicant for RAPITEX(R) ASL NEW?

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

What is the FDA product code for RAPITEX(R) ASL NEW?

The FDA product code for RAPITEX(R) ASL NEW is GTQ.

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Other records listing Behring 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.

K973832OPUS HLH CONTROLSK972929N ANTISERUM TO HUMAN ALBUMINK972840N ANTISERUM TO HUMAN TRANSFERRINK973202MODIFICATION OF OPUS FERRITIN TEST SYSTEMK972316OPUS D-DIMERK972116VON WILLEBRAND REAGENT

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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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