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FDA 510(k)

ENCORE ENA COMBINED EIA

K-Number: K931543 · 1993-09-08

ApplicantClark Laboratories, Inc.
Decision Date1993-09-08
Product CodeLLL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ENCORE ENA COMBINED EIA is the device name listed in this FDA 510(k) record. The listed applicant is Clark Laboratories, Inc.. It received FDA 510(k) clearance on 1993-09-08 under 510(k) number K931543. 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 ENCORE ENA COMBINED EIA?

ENCORE ENA COMBINED EIA is a medical device that received FDA 510(k) clearance on 1993-09-08. The listed applicant is Clark Laboratories, Inc.. The 510(k) number is K931543.

When did ENCORE ENA COMBINED EIA receive FDA 510(k) clearance?

ENCORE ENA COMBINED EIA received FDA 510(k) clearance on 1993-09-08, under 510(k) number K931543.

Who is the listed applicant for ENCORE ENA COMBINED EIA?

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

What is the FDA product code for ENCORE ENA COMBINED EIA?

The FDA product code for ENCORE ENA COMBINED EIA is LLL.

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Other records listing Clark Laboratories, 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.

K980912VCA IGG ELISA TEST SYSTEMK980596VCA IGM ELISA TEST SYSTEMK980598EBNA-1 IGM ELISA TEST SYSTEMK973123EA-D IGG ELISA TEST SYSTEMK925826ENCORE THYROGLOBULIN IGE, IGA AND IGM EIAK923537ENCORE DS-DNA

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Related Devices (Code: LLL)

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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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