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FDA 510(k)

ORGEN TEC ANTI-DSDNA ELISA ASSAY

K-Number: K953671 · 1995-11-09

ApplicantOrgentec
Decision Date1995-11-09
Product CodeLRM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ORGEN TEC ANTI-DSDNA ELISA ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Orgentec. It received FDA 510(k) clearance on 1995-11-09 under 510(k) number K953671. 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 ORGEN TEC ANTI-DSDNA ELISA ASSAY?

ORGEN TEC ANTI-DSDNA ELISA ASSAY is a medical device that received FDA 510(k) clearance on 1995-11-09. The listed applicant is Orgentec. The 510(k) number is K953671.

When did ORGEN TEC ANTI-DSDNA ELISA ASSAY receive FDA 510(k) clearance?

ORGEN TEC ANTI-DSDNA ELISA ASSAY received FDA 510(k) clearance on 1995-11-09, under 510(k) number K953671.

Who is the listed applicant for ORGEN TEC ANTI-DSDNA ELISA ASSAY?

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

What is the FDA product code for ORGEN TEC ANTI-DSDNA ELISA ASSAY?

The FDA product code for ORGEN TEC ANTI-DSDNA ELISA ASSAY is LRM.

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Other records listing Orgentec 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.

K954830ORGENTEC ANTI-SM(SMITH) PIN IMMUNO ASSAYK954831ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAYK954815ORGENTEC ANTI-SS-A(RO) PIN IMMUNO ASSAYK954814ORGENTEC ANTI-SCL 70 PIN IMMUNO ASSAYK954832ORGENTEC ANTI-SS-B(LA) PIN IMMUNO ASSAYK954829ORGENTEC ANTI-JO-1 PIN IMMUNO ASSAY

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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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