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FDA 510(k)

ACCUBIND NEO-TSH MICROWELL ELISA, MODEL 3425-300

K-Number: K063437 · 2008-04-04

ApplicantMonobind, Inc.
Decision Date2008-04-04
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACCUBIND NEO-TSH MICROWELL ELISA, MODEL 3425-300 is the device name listed in this FDA 510(k) record. The listed applicant is Monobind, Inc.. It received FDA 510(k) clearance on 2008-04-04 under 510(k) number K063437. The device is classified under product code JLW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCUBIND NEO-TSH MICROWELL ELISA, MODEL 3425-300?

ACCUBIND NEO-TSH MICROWELL ELISA, MODEL 3425-300 is a medical device that received FDA 510(k) clearance on 2008-04-04. The listed applicant is Monobind, Inc.. The 510(k) number is K063437.

When did ACCUBIND NEO-TSH MICROWELL ELISA, MODEL 3425-300 receive FDA 510(k) clearance?

ACCUBIND NEO-TSH MICROWELL ELISA, MODEL 3425-300 received FDA 510(k) clearance on 2008-04-04, under 510(k) number K063437.

Who is the listed applicant for ACCUBIND NEO-TSH MICROWELL ELISA, MODEL 3425-300?

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

What is the FDA product code for ACCUBIND NEO-TSH MICROWELL ELISA, MODEL 3425-300?

The FDA product code for ACCUBIND NEO-TSH MICROWELL ELISA, MODEL 3425-300 is JLW.

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Related Devices (Code: JLW)

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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