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FDA 510(k)

ENCORE SM

K-Number: K921572 · 1992-12-01

ApplicantClark Laboratories, Inc.
Decision Date1992-12-01
Product CodeLLL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ENCORE SM 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 1992-12-01 under 510(k) number K921572. 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 SM?

ENCORE SM is a medical device that received FDA 510(k) clearance on 1992-12-01. The listed applicant is Clark Laboratories, Inc.. The 510(k) number is K921572.

When did ENCORE SM receive FDA 510(k) clearance?

ENCORE SM received FDA 510(k) clearance on 1992-12-01, under 510(k) number K921572.

Who is the listed applicant for ENCORE SM?

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 SM?

The FDA product code for ENCORE SM 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 SYSTEMK931543ENCORE ENA COMBINED EIAK925826ENCORE THYROGLOBULIN IGE, IGA AND IGM EIA

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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.

K253817IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/LaImmunodiagnostics Systems LimitedK253367EliA CTD 13 ScreenPhadia ABK250666Alegria Flash CTD ScreenZeus ScientificK250408Alegria Flash ENA ScreenZeus ScientificK213403Aptiva CTD Essential ReagentInova Diagnostics, Inc.K190710EliA SymphonyS ImmunoassayPhadia AB

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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