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FDA 510(k)

SYNELISA CARDIOLIPIN ANTIBODIES

K-Number: K921250 · 1992-06-04

ApplicantElias U.S.A., Inc.
Decision Date1992-06-04
Product CodeMID
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

SYNELISA CARDIOLIPIN 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 1992-06-04 under 510(k) number K921250. The device is classified under product code MID. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNELISA CARDIOLIPIN ANTIBODIES?

SYNELISA CARDIOLIPIN ANTIBODIES is a medical device that received FDA 510(k) clearance on 1992-06-04. The listed applicant is Elias U.S.A., Inc.. The 510(k) number is K921250.

When did SYNELISA CARDIOLIPIN ANTIBODIES receive FDA 510(k) clearance?

SYNELISA CARDIOLIPIN ANTIBODIES received FDA 510(k) clearance on 1992-06-04, under 510(k) number K921250.

Who is the listed applicant for SYNELISA CARDIOLIPIN 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 CARDIOLIPIN ANTIBODIES?

The FDA product code for SYNELISA CARDIOLIPIN ANTIBODIES is MID.

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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: MID)

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.

K223093Aptiva APS IgG Reagent; Aptiva APS IgM ReagentInova Diagnostics, Inc.K131821ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAYPhadia US, Inc.K130528BIOPLEX 2200 APLS IGMBio-Rad LaboratoriesK120817QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGAInova Diagnostics, Inc.K113020IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISASImmco Diagnostics, Inc.K103834BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETSBio-Rad Laboratories

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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