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FDA 510(k)

CREATININE REAGENT SET

K-Number: K841070 · 1984-05-01

ApplicantMedical Specialties, Inc.
Decision Date1984-05-01
Product CodeJFY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CREATININE REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Medical Specialties, Inc.. It received FDA 510(k) clearance on 1984-05-01 under 510(k) number K841070. The device is classified under product code JFY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CREATININE REAGENT SET?

CREATININE REAGENT SET is a medical device that received FDA 510(k) clearance on 1984-05-01. The listed applicant is Medical Specialties, Inc.. The 510(k) number is K841070.

When did CREATININE REAGENT SET receive FDA 510(k) clearance?

CREATININE REAGENT SET received FDA 510(k) clearance on 1984-05-01, under 510(k) number K841070.

Who is the listed applicant for CREATININE REAGENT SET?

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

What is the FDA product code for CREATININE REAGENT SET?

The FDA product code for CREATININE REAGENT SET is JFY.

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Other records listing Medical Specialties, 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.

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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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