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FDA 510(k)

GLUCOSTIX REAGENT STRIPS & GLUCOMETER REFLECT-PHOT

K-Number: K851703 · 1985-08-23

ApplicantMiles Laboratories, Inc.
Decision Date1985-08-23
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOSTIX REAGENT STRIPS & GLUCOMETER REFLECT-PHOT is the device name listed in this FDA 510(k) record. The listed applicant is Miles Laboratories, Inc.. It received FDA 510(k) clearance on 1985-08-23 under 510(k) number K851703. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLUCOSTIX REAGENT STRIPS & GLUCOMETER REFLECT-PHOT?

GLUCOSTIX REAGENT STRIPS & GLUCOMETER REFLECT-PHOT is a medical device that received FDA 510(k) clearance on 1985-08-23. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K851703.

When did GLUCOSTIX REAGENT STRIPS & GLUCOMETER REFLECT-PHOT receive FDA 510(k) clearance?

GLUCOSTIX REAGENT STRIPS & GLUCOMETER REFLECT-PHOT received FDA 510(k) clearance on 1985-08-23, under 510(k) number K851703.

Who is the listed applicant for GLUCOSTIX REAGENT STRIPS & GLUCOMETER REFLECT-PHOT?

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

What is the FDA product code for GLUCOSTIX REAGENT STRIPS & GLUCOMETER REFLECT-PHOT?

The FDA product code for GLUCOSTIX REAGENT STRIPS & GLUCOMETER REFLECT-PHOT is CGA.

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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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