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FDA 510(k)

NICCHECK I

K-Number: K963733 · 1996-12-13

ApplicantDynagen, Inc.
Decision Date1996-12-13
Product CodeMRS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

NICCHECK I is the device name listed in this FDA 510(k) record. The listed applicant is Dynagen, Inc.. It received FDA 510(k) clearance on 1996-12-13 under 510(k) number K963733. The device is classified under product code MRS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NICCHECK I?

NICCHECK I is a medical device that received FDA 510(k) clearance on 1996-12-13. The listed applicant is Dynagen, Inc.. The 510(k) number is K963733.

When did NICCHECK I receive FDA 510(k) clearance?

NICCHECK I received FDA 510(k) clearance on 1996-12-13, under 510(k) number K963733.

Who is the listed applicant for NICCHECK I?

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

What is the FDA product code for NICCHECK I?

The FDA product code for NICCHECK I is MRS.

Related Clinical Trials

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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Other records listing Dynagen, 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.

K943051MYCOAKT M. TUBERCULOSIS CUULTURE ID KITK943050MYCOAKT M KANSASII CULTURE ID KITK943049MYCOAKT M. AVIUM CULTURE ID KITK931105PROCHECK(TM) BLIND PERFORMANCE SPECIMENSK912888URITEC TEST STRIP & HUMAN URINE + & - TEST CONTROL

Related Devices (Code: MRS)

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.

K030649DRI COTININE EIA ASSAYMicrogenics Corp.K021688NICALERTNymox Pharmaceutical Corporation

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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