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FDA 510(k)

ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA

K-Number: K971834 · 1997-07-03

ApplicantMonobind
Decision Date1997-07-03
Product CodeJNL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA is the device name listed in this FDA 510(k) record. The listed applicant is Monobind. It received FDA 510(k) clearance on 1997-07-03 under 510(k) number K971834. 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 ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA?

ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA is a medical device that received FDA 510(k) clearance on 1997-07-03. The listed applicant is Monobind. The 510(k) number is K971834.

When did ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA receive FDA 510(k) clearance?

ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA received FDA 510(k) clearance on 1997-07-03, under 510(k) number K971834.

Who is the listed applicant for ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA?

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

What is the FDA product code for ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA?

The FDA product code for ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA is JNL.

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Other records listing Monobind 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.

K030860ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300K020548FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300K980088T-UPTAKE MICROPLATE EIAK972720FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300)K971835ANTI-THYROGLOBULIN (TG) MICROPLATE ELISAK971921PROLACTIN (PRL) HORMONE MICROPLATE ELISA

View all 21 devices →

Related Devices (Code: JNL)

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.

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.K962341HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROGLOBULIN (TG)Hycor Biomedical, 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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