Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

NIACIN REAGENT STRIP

K-Number: K840981 · 1984-03-23

ApplicantRemel Co.
Decision Date1984-03-23
Product CodeMJD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

NIACIN REAGENT STRIP is the device name listed in this FDA 510(k) record. The listed applicant is Remel Co.. It received FDA 510(k) clearance on 1984-03-23 under 510(k) number K840981. The device is classified under product code MJD. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NIACIN REAGENT STRIP?

NIACIN REAGENT STRIP is a medical device that received FDA 510(k) clearance on 1984-03-23. The listed applicant is Remel Co.. The 510(k) number is K840981.

When did NIACIN REAGENT STRIP receive FDA 510(k) clearance?

NIACIN REAGENT STRIP received FDA 510(k) clearance on 1984-03-23, under 510(k) number K840981.

Who is the listed applicant for NIACIN REAGENT STRIP?

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

What is the FDA product code for NIACIN REAGENT STRIP?

The FDA product code for NIACIN REAGENT STRIP is MJD.

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.

Other records listing Remel Co. 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.

View all 137 devices →

Related Devices (Code: MJD)

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.

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.

↑