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FDA 510(k)

ANTI-RNP AND ANTI-SM ANTIBODY TEST

K-Number: K895338 · 1989-10-17

ApplicantImmco Diagnostics, Inc.
Decision Date1989-10-17
Product CodeLKO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANTI-RNP AND ANTI-SM ANTIBODY TEST is the device name listed in this FDA 510(k) record. The listed applicant is Immco Diagnostics, Inc.. It received FDA 510(k) clearance on 1989-10-17 under 510(k) number K895338. 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 ANTI-RNP AND ANTI-SM ANTIBODY TEST?

ANTI-RNP AND ANTI-SM ANTIBODY TEST is a medical device that received FDA 510(k) clearance on 1989-10-17. The listed applicant is Immco Diagnostics, Inc.. The 510(k) number is K895338.

When did ANTI-RNP AND ANTI-SM ANTIBODY TEST receive FDA 510(k) clearance?

ANTI-RNP AND ANTI-SM ANTIBODY TEST received FDA 510(k) clearance on 1989-10-17, under 510(k) number K895338.

Who is the listed applicant for ANTI-RNP AND ANTI-SM ANTIBODY TEST?

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

What is the FDA product code for ANTI-RNP AND ANTI-SM ANTIBODY TEST?

The FDA product code for ANTI-RNP AND ANTI-SM ANTIBODY TEST is LKO.

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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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