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FDA 510(k)

IMMUNO/ASO

K-Number: K894780 · 1989-10-16

ApplicantImmunostics Co., Inc.
Decision Date1989-10-16
Product CodeGTQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IMMUNO/ASO is the device name listed in this FDA 510(k) record. The listed applicant is Immunostics Co., Inc.. It received FDA 510(k) clearance on 1989-10-16 under 510(k) number K894780. 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 IMMUNO/ASO?

IMMUNO/ASO is a medical device that received FDA 510(k) clearance on 1989-10-16. The listed applicant is Immunostics Co., Inc.. The 510(k) number is K894780.

When did IMMUNO/ASO receive FDA 510(k) clearance?

IMMUNO/ASO received FDA 510(k) clearance on 1989-10-16, under 510(k) number K894780.

Who is the listed applicant for IMMUNO/ASO?

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

What is the FDA product code for IMMUNO/ASO?

The FDA product code for IMMUNO/ASO is GTQ.

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Other records listing Immunostics Co., 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.

K926569IMMUNO RA UNDILUTEDK902360HEMA-SCREENK883685IMMUNO/FEBRILE ANTIGENSK872910IMMUNO/SLEK863741IMMUNO-CEPT D (BETA-MONOCLONAL)K854619DETECTACULT

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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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