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FDA 510(k)

SYNELISA TGAB

K-Number: K915134 · 1992-04-08

ApplicantElias U.S.A., Inc.
Decision Date1992-04-08
Product CodeJZO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

SYNELISA TGAB 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 1992-04-08 under 510(k) number K915134. The device is classified under product code JZO. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNELISA TGAB?

SYNELISA TGAB is a medical device that received FDA 510(k) clearance on 1992-04-08. The listed applicant is Elias U.S.A., Inc.. The 510(k) number is K915134.

When did SYNELISA TGAB receive FDA 510(k) clearance?

SYNELISA TGAB received FDA 510(k) clearance on 1992-04-08, under 510(k) number K915134.

Who is the listed applicant for SYNELISA TGAB?

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 TGAB?

The FDA product code for SYNELISA TGAB is JZO.

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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: JZO)

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.

K250250ADVIA Centaur Anti-Thyroid Peroxidase IISiemens Healthcare Diagnostics, Inc.K240469Access TPO AntibodyBeckman Coulter, Inc.K213517Access Thyroglobulin Antibody IIBeckman Coulter, Inc.K222610Elecsys Anti-TgRoche DiagnosticsK193313Elecsys Anti-TSHRRoche DiagnosticsK151799EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000Phadia AB

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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