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FDA 510(k)

URISTRIP REAGENT STRIPS TEST FOR PROTEIN, GLUCOSE, PH AND BLOOD

K-Number: K946116 · 1995-03-21

ApplicantChemtech Labs, Inc.
Decision Date1995-03-21
Product CodeJIL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

URISTRIP REAGENT STRIPS TEST FOR PROTEIN, GLUCOSE, PH AND BLOOD is the device name listed in this FDA 510(k) record. The listed applicant is Chemtech Labs, Inc.. It received FDA 510(k) clearance on 1995-03-21 under 510(k) number K946116. The device is classified under product code JIL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URISTRIP REAGENT STRIPS TEST FOR PROTEIN, GLUCOSE, PH AND BLOOD?

URISTRIP REAGENT STRIPS TEST FOR PROTEIN, GLUCOSE, PH AND BLOOD is a medical device that received FDA 510(k) clearance on 1995-03-21. The listed applicant is Chemtech Labs, Inc.. The 510(k) number is K946116.

When did URISTRIP REAGENT STRIPS TEST FOR PROTEIN, GLUCOSE, PH AND BLOOD receive FDA 510(k) clearance?

URISTRIP REAGENT STRIPS TEST FOR PROTEIN, GLUCOSE, PH AND BLOOD received FDA 510(k) clearance on 1995-03-21, under 510(k) number K946116.

Who is the listed applicant for URISTRIP REAGENT STRIPS TEST FOR PROTEIN, GLUCOSE, PH AND BLOOD?

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

What is the FDA product code for URISTRIP REAGENT STRIPS TEST FOR PROTEIN, GLUCOSE, PH AND BLOOD?

The FDA product code for URISTRIP REAGENT STRIPS TEST FOR PROTEIN, GLUCOSE, PH AND BLOOD is JIL.

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Official Source

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