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FDA 510(k)

SYNELISA U1-SNRNP (68KDA)-ANTIBODIES

K-Number: K930142 · 1993-05-11

ApplicantElias U.S.A., Inc.
Decision Date1993-05-11
Product CodeLKO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

SYNELISA U1-SNRNP (68KDA)-ANTIBODIES is the device name listed in this FDA 510(k) record. The listed applicant is Elias U.S.A., Inc.. It received FDA 510(k) clearance on 1993-05-11 under 510(k) number K930142. 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 SYNELISA U1-SNRNP (68KDA)-ANTIBODIES?

SYNELISA U1-SNRNP (68KDA)-ANTIBODIES is a medical device that received FDA 510(k) clearance on 1993-05-11. The listed applicant is Elias U.S.A., Inc.. The 510(k) number is K930142.

When did SYNELISA U1-SNRNP (68KDA)-ANTIBODIES receive FDA 510(k) clearance?

SYNELISA U1-SNRNP (68KDA)-ANTIBODIES received FDA 510(k) clearance on 1993-05-11, under 510(k) number K930142.

Who is the listed applicant for SYNELISA U1-SNRNP (68KDA)-ANTIBODIES?

The FDA 510(k) record lists Elias U.S.A., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYNELISA U1-SNRNP (68KDA)-ANTIBODIES?

The FDA product code for SYNELISA U1-SNRNP (68KDA)-ANTIBODIES is LKO.

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Other records listing Elias U.S.A., Inc. 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.

K964385ELIAS ANA-HEP-2K963291VARELISA ANA (4) PROFILEK953873VARELISA HELICOBACTER PYLORI ANTIBODIESK953587VARELISA MPO-ANCAK953586VARELISA PR3-ANCAK951187VARELISA CARDIOLIPIN ABS SCREEN

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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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