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FDA 510(k)

SELISA ANTI-N DNA ANTIBODIES

K-Number: K940585 · 1994-06-10

ApplicantCambridge Life Sciences Plc.
Decision Date1994-06-10
Product CodeLRM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

SELISA ANTI-N DNA ANTIBODIES is the device name listed in this FDA 510(k) record. The listed applicant is Cambridge Life Sciences Plc.. It received FDA 510(k) clearance on 1994-06-10 under 510(k) number K940585. 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 SELISA ANTI-N DNA ANTIBODIES?

SELISA ANTI-N DNA ANTIBODIES is a medical device that received FDA 510(k) clearance on 1994-06-10. The listed applicant is Cambridge Life Sciences Plc.. The 510(k) number is K940585.

When did SELISA ANTI-N DNA ANTIBODIES receive FDA 510(k) clearance?

SELISA ANTI-N DNA ANTIBODIES received FDA 510(k) clearance on 1994-06-10, under 510(k) number K940585.

Who is the listed applicant for SELISA ANTI-N DNA ANTIBODIES?

The FDA 510(k) record lists Cambridge Life Sciences Plc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SELISA ANTI-N DNA ANTIBODIES?

The FDA product code for SELISA ANTI-N DNA ANTIBODIES is LRM.

Related Clinical Trials

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Other records listing Cambridge Life Sciences Plc. 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.

K940700AUTOZYME SCREENK922241AUTOZYMEK891869CLS 962 MICROPLATE PHOTOMETER

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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