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FDA 510(k)

ENCORE SM/RNP

K-Number: K921870 · 1992-12-01

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

Device Summary

ENCORE SM/RNP 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 K921870. 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/RNP?

ENCORE SM/RNP 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 K921870.

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

ENCORE SM/RNP received FDA 510(k) clearance on 1992-12-01, under 510(k) number K921870.

Who is the listed applicant for ENCORE SM/RNP?

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/RNP?

The FDA product code for ENCORE SM/RNP 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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