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FDA 510(k)

GLUCOMETER II IMPROVED REFLECTANCE PHOTOMETER

K-Number: K861303 · 1986-07-02

ApplicantMiles Laboratories, Inc.
Decision Date1986-07-02
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOMETER II IMPROVED REFLECTANCE PHOTOMETER 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 1986-07-02 under 510(k) number K861303. 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 GLUCOMETER II IMPROVED REFLECTANCE PHOTOMETER?

GLUCOMETER II IMPROVED REFLECTANCE PHOTOMETER is a medical device that received FDA 510(k) clearance on 1986-07-02. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K861303.

When did GLUCOMETER II IMPROVED REFLECTANCE PHOTOMETER receive FDA 510(k) clearance?

GLUCOMETER II IMPROVED REFLECTANCE PHOTOMETER received FDA 510(k) clearance on 1986-07-02, under 510(k) number K861303.

Who is the listed applicant for GLUCOMETER II IMPROVED REFLECTANCE PHOTOMETER?

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 GLUCOMETER II IMPROVED REFLECTANCE PHOTOMETER?

The FDA product code for GLUCOMETER II IMPROVED REFLECTANCE PHOTOMETER 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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