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FDA 510(k)

THE APTUS (AUTOMATED) APPLICATION OF THE HM-CAP EIA KIT. AN ENZYME LINKED IMMUNOSORBENT ASSAY FOR THE DETECTION OF THE S

K-Number: K984544 · 1999-02-18

ApplicantEnteric Products, Inc.
Decision Date1999-02-18
Product CodeLYR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

THE APTUS (AUTOMATED) APPLICATION OF THE HM-CAP EIA KIT. AN ENZYME LINKED IMMUNOSORBENT ASSAY FOR THE DETECTION OF THE S is the device name listed in this FDA 510(k) record. The listed applicant is Enteric Products, Inc.. It received FDA 510(k) clearance on 1999-02-18 under 510(k) number K984544. The device is classified under product code LYR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE APTUS (AUTOMATED) APPLICATION OF THE HM-CAP EIA KIT. AN ENZYME LINKED IMMUNOSORBENT ASSAY FOR THE DETECTION OF THE S?

THE APTUS (AUTOMATED) APPLICATION OF THE HM-CAP EIA KIT. AN ENZYME LINKED IMMUNOSORBENT ASSAY FOR THE DETECTION OF THE S is a medical device that received FDA 510(k) clearance on 1999-02-18. The listed applicant is Enteric Products, Inc.. The 510(k) number is K984544.

When did THE APTUS (AUTOMATED) APPLICATION OF THE HM-CAP EIA KIT. AN ENZYME LINKED IMMUNOSORBENT ASSAY FOR THE DETECTION OF THE S receive FDA 510(k) clearance?

THE APTUS (AUTOMATED) APPLICATION OF THE HM-CAP EIA KIT. AN ENZYME LINKED IMMUNOSORBENT ASSAY FOR THE DETECTION OF THE S received FDA 510(k) clearance on 1999-02-18, under 510(k) number K984544.

Who is the listed applicant for THE APTUS (AUTOMATED) APPLICATION OF THE HM-CAP EIA KIT. AN ENZYME LINKED IMMUNOSORBENT ASSAY FOR THE DETECTION OF THE S?

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

What is the FDA product code for THE APTUS (AUTOMATED) APPLICATION OF THE HM-CAP EIA KIT. AN ENZYME LINKED IMMUNOSORBENT ASSAY FOR THE DETECTION OF THE S?

The FDA product code for THE APTUS (AUTOMATED) APPLICATION OF THE HM-CAP EIA KIT. AN ENZYME LINKED IMMUNOSORBENT ASSAY FOR THE DETECTION OF THE S is LYR.

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 Enteric Products, 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.

K001177PP-CAP EIA FOR THE DETECTION OF IGA ANTIBODIES TO H. PYLORI

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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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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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