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FDA 510(k)

ELISA TOXO IGM

K-Number: K914852 · 1992-01-23

ApplicantSclavo, Inc.
Decision Date1992-01-23
Product CodeLGD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ELISA TOXO IGM is the device name listed in this FDA 510(k) record. The listed applicant is Sclavo, Inc.. It received FDA 510(k) clearance on 1992-01-23 under 510(k) number K914852. The device is classified under product code LGD. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELISA TOXO IGM?

ELISA TOXO IGM is a medical device that received FDA 510(k) clearance on 1992-01-23. The listed applicant is Sclavo, Inc.. The 510(k) number is K914852.

When did ELISA TOXO IGM receive FDA 510(k) clearance?

ELISA TOXO IGM received FDA 510(k) clearance on 1992-01-23, under 510(k) number K914852.

Who is the listed applicant for ELISA TOXO IGM?

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

What is the FDA product code for ELISA TOXO IGM?

The FDA product code for ELISA TOXO IGM is LGD.

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Other records listing Sclavo, 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.

K914789ELISA CMV IGMK914420ELISA RUBELLA IGMK895943NORMAL AND ABNORMAL CONTROL SERAK895822TOTAL BILIRUBIN L.F.K895847CREATININE 340 (ENZYMATIC)K873496ATYPICAL CHOLINESTERASE

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Related Devices (Code: LGD)

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.

K242022Access Toxo IgGBeckman Coulter, Inc.K242095Access Toxo IgM IIBeckman Coulter, Inc.K233932Alinity i Toxo IgMAbbott LaboratoriesK210596ARCHITECT Toxo IgGAbbott LaboratoriesK162678Elecsys Toxo IgM, Elecsys Toxo IgM PreciControlRoche DiagnosticsK132234LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG IIDiaSorin, 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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