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FDA 510(k)

ORGENTEC ANTI-SS-A(RO) PIN IMMUNO ASSAY

K-Number: K954815 · 1996-04-18

ApplicantOrgentec
Decision Date1996-04-18
Product CodeLJM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ORGENTEC ANTI-SS-A(RO) PIN IMMUNO ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Orgentec. It received FDA 510(k) clearance on 1996-04-18 under 510(k) number K954815. The device is classified under product code LJM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORGENTEC ANTI-SS-A(RO) PIN IMMUNO ASSAY?

ORGENTEC ANTI-SS-A(RO) PIN IMMUNO ASSAY is a medical device that received FDA 510(k) clearance on 1996-04-18. The listed applicant is Orgentec. The 510(k) number is K954815.

When did ORGENTEC ANTI-SS-A(RO) PIN IMMUNO ASSAY receive FDA 510(k) clearance?

ORGENTEC ANTI-SS-A(RO) PIN IMMUNO ASSAY received FDA 510(k) clearance on 1996-04-18, under 510(k) number K954815.

Who is the listed applicant for ORGENTEC ANTI-SS-A(RO) PIN IMMUNO 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 ORGENTEC ANTI-SS-A(RO) PIN IMMUNO ASSAY?

The FDA product code for ORGENTEC ANTI-SS-A(RO) PIN IMMUNO ASSAY is LJM.

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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 ASSAYK954832ORGENTEC ANTI-SS-B(LA) PIN IMMUNO ASSAYK954814ORGENTEC ANTI-SCL 70 PIN IMMUNO ASSAYK954829ORGENTEC ANTI-JO-1 PIN IMMUNO ASSAYK960274ORGENTEC MICRO-ALBUMIN PIN EIA ASSAY

View all 10 devices →

Related Devices (Code: LJM)

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.

K182353EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 ImmunoassayPhadia ABK151559ImmuLisa Enhanced Centromere Antibody ELISAImmco Diagnostics, Inc.K131185ANA SCREEN ELISA (IGG)Euroimmun USK083188VARELISA RECOMBI ANA SCREEN, MODEL 12 596Phadia US, Inc.K050967VARELISA RECOMBI CTD SCREEN, MODEL 13096Sweden Diagnostics (Germany) GmbHK050625VARELISA RECOMBI ANA PROFILE, MODEL 18496Sweden Diagnostics (Germany) GmbH

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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