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FDA 510(k)

ENCORE DS-DNA

K-Number: K923537 · 1992-12-23

ApplicantClark Laboratories, Inc.
Decision Date1992-12-23
Product CodeLRM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ENCORE DS-DNA 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 1992-12-23 under 510(k) number K923537. The device is classified under product code LRM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENCORE DS-DNA?

ENCORE DS-DNA is a medical device that received FDA 510(k) clearance on 1992-12-23. The listed applicant is Clark Laboratories, Inc.. The 510(k) number is K923537.

When did ENCORE DS-DNA receive FDA 510(k) clearance?

ENCORE DS-DNA received FDA 510(k) clearance on 1992-12-23, under 510(k) number K923537.

Who is the listed applicant for ENCORE DS-DNA?

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 DS-DNA?

The FDA product code for ENCORE DS-DNA is LRM.

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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.

K980596VCA IGM ELISA TEST SYSTEMK980912VCA IGG 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: LRM)

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.

K101319IMMULISA DSDNA ANTIBODY ELISAImmco Diagnostics, Inc.K083381EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG)Euroimmun Us, Inc.K062183FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KITThe Binding Site, Ltd.K040811VARELISA SSDNA ANTIBODIES, MODEL 14896Pharmacia Deutschland GmbHK001900ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TESTHelix Diagnostics, Inc.K000477MDI DS-DNA TESTMicro Detect, Inc.

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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