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FDA 510(k)

SYNELISA TPO ANTIBODIES

K-Number: K921787 · 1992-07-28

ApplicantElias U.S.A., Inc.
Decision Date1992-07-28
Product CodeJNL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

SYNELISA TPO 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 1992-07-28 under 510(k) number K921787. The device is classified under product code JNL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNELISA TPO ANTIBODIES?

SYNELISA TPO ANTIBODIES is a medical device that received FDA 510(k) clearance on 1992-07-28. The listed applicant is Elias U.S.A., Inc.. The 510(k) number is K921787.

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

SYNELISA TPO ANTIBODIES received FDA 510(k) clearance on 1992-07-28, under 510(k) number K921787.

Who is the listed applicant for SYNELISA TPO 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 TPO ANTIBODIES?

The FDA product code for SYNELISA TPO ANTIBODIES is JNL.

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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: JNL)

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K250816ADVIA Centaur Anti-Thyroglobulin II (aTgII)Siemens Healthcare Diagnostics, Inc.K240996Access Thyroglobulin Antibody IIBeckman Coulter, Inc.K112933ACCESS THYROGLOBULIN ANITBODYBeckman Coulter, Inc.K072661IMMUNOCAP THYRLOBULIN IMMUNOCAPPhadia US, Inc.K062516ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS)Beckman Coulter, Inc.K971834ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISAMonobind

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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