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FDA 510(k)

ASO SLIDE EIKEN

K-Number: K853276 · 1985-08-20

ApplicantSyn-Kit, Inc.
Decision Date1985-08-20
Product CodeGTQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ASO SLIDE EIKEN is the device name listed in this FDA 510(k) record. The listed applicant is Syn-Kit, Inc.. It received FDA 510(k) clearance on 1985-08-20 under 510(k) number K853276. 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 ASO SLIDE EIKEN?

ASO SLIDE EIKEN is a medical device that received FDA 510(k) clearance on 1985-08-20. The listed applicant is Syn-Kit, Inc.. The 510(k) number is K853276.

When did ASO SLIDE EIKEN receive FDA 510(k) clearance?

ASO SLIDE EIKEN received FDA 510(k) clearance on 1985-08-20, under 510(k) number K853276.

Who is the listed applicant for ASO SLIDE EIKEN?

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

What is the FDA product code for ASO SLIDE EIKEN?

The FDA product code for ASO SLIDE EIKEN 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 Syn-Kit, 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.

K861098SEROIDEN STREPTO KIT 'EIKEN'K861631SLIDE CULTURE U 'EIKEN'K854819CPR SLIDE EIKENK854820RA 80 EIKENK843758UROPAPER EIKEN GKK843753UROPAPER EIKEN GP

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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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