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FDA 510(k)

AUTOSTAT II ANTI-JO-1 ELISA

K-Number: K990798 · 1999-04-28

ApplicantCogent Diagnotics , Ltd.
Decision Date1999-04-28
Product CodeLLL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AUTOSTAT II ANTI-JO-1 ELISA is the device name listed in this FDA 510(k) record. The listed applicant is Cogent Diagnotics , Ltd.. It received FDA 510(k) clearance on 1999-04-28 under 510(k) number K990798. The device is classified under product code LLL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOSTAT II ANTI-JO-1 ELISA?

AUTOSTAT II ANTI-JO-1 ELISA is a medical device that received FDA 510(k) clearance on 1999-04-28. The listed applicant is Cogent Diagnotics , Ltd.. The 510(k) number is K990798.

When did AUTOSTAT II ANTI-JO-1 ELISA receive FDA 510(k) clearance?

AUTOSTAT II ANTI-JO-1 ELISA received FDA 510(k) clearance on 1999-04-28, under 510(k) number K990798.

Who is the listed applicant for AUTOSTAT II ANTI-JO-1 ELISA?

The FDA 510(k) record lists Cogent Diagnotics , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUTOSTAT II ANTI-JO-1 ELISA?

The FDA product code for AUTOSTAT II ANTI-JO-1 ELISA is LLL.

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Other records listing Cogent Diagnotics , Ltd. as applicant

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Related Devices (Code: LLL)

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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