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FDA 510(k)

ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAY

K-Number: K954831 · 1996-05-08

ApplicantOrgentec
Decision Date1996-05-08
Product CodeLKO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ORGENTEC ANTI-RNP/SM 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 1996-05-08 under 510(k) number K954831. The device is classified under product code LKO. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAY?

ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAY is a medical device that received FDA 510(k) clearance on 1996-05-08. The listed applicant is Orgentec. The 510(k) number is K954831.

When did ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAY receive FDA 510(k) clearance?

ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAY received FDA 510(k) clearance on 1996-05-08, under 510(k) number K954831.

Who is the listed applicant for ORGENTEC ANTI-RNP/SM 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-RNP/SM PIN IMMUNO ASSAY?

The FDA product code for ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAY is LKO.

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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 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 ASSAYK960274ORGENTEC MICRO-ALBUMIN PIN EIA ASSAY

View all 10 devices →

Related Devices (Code: LKO)

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.

K191085Maverick RNP Assay and Maverick Diagnostic SystemGenalyte, Inc.K123261EUROIMMUN ANTI-NRNP/SM ELISA (IGG)Euroimmun USK083117ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODELS 14-5511-01, 14-5506-01 AND 14-5507-01Phadia US, Inc.K071210MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006Biomedical Diagnostics (Bmd) SAK022017RHIGENE MESACUP-2 TEST RNP, MODEL M7741Rhigene, Inc.K000752RHIGENE MESACUP2 TEST- RNPRhigene, 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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