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FDA 510(k)

ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300

K-Number: K030860 · 2003-08-22

ApplicantMonobind
Decision Date2003-08-22
Product CodeKLI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300 is the device name listed in this FDA 510(k) record. The listed applicant is Monobind. It received FDA 510(k) clearance on 2003-08-22 under 510(k) number K030860. The device is classified under product code KLI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300?

ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300 is a medical device that received FDA 510(k) clearance on 2003-08-22. The listed applicant is Monobind. The 510(k) number is K030860.

When did ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300 receive FDA 510(k) clearance?

ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300 received FDA 510(k) clearance on 2003-08-22, under 510(k) number K030860.

Who is the listed applicant for ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300?

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 ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300?

The FDA product code for ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300 is KLI.

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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.

K020548FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300K980088T-UPTAKE MICROPLATE EIAK972720FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300)K971834ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISAK971835ANTI-THYROGLOBULIN (TG) MICROPLATE ELISAK971921PROLACTIN (PRL) HORMONE MICROPLATE ELISA

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Related Devices (Code: KLI)

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.

K160495VITROS® Automation SolutionsOrtho-Clinical Diagnostics, Inc.K131515ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENTAlfa WassermannK103484GSP NEONATAL THYROXINE (T4)Wallac Oy, A Subsidiary of Perkinelmer, Inc.K082638ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELLSiemens Healthcare Diagnostics, Inc.K023369ACCESS TOTAL T4 ASSAYBeckman Coulter, Inc.K001603REPROBEAD T4 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 105)Repromedix Corp.

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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