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FDA 510(k)

AMES GLUCOMETER REFLECT. PHOTOMETER

K-Number: K801044 · 1980-06-02

ApplicantMiles Laboratories, Inc.
Decision Date1980-06-02
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMES GLUCOMETER REFLECT. 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 1980-06-02 under 510(k) number K801044. The device is classified under product code JJQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMES GLUCOMETER REFLECT. PHOTOMETER?

AMES GLUCOMETER REFLECT. PHOTOMETER is a medical device that received FDA 510(k) clearance on 1980-06-02. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K801044.

When did AMES GLUCOMETER REFLECT. PHOTOMETER receive FDA 510(k) clearance?

AMES GLUCOMETER REFLECT. PHOTOMETER received FDA 510(k) clearance on 1980-06-02, under 510(k) number K801044.

Who is the listed applicant for AMES GLUCOMETER REFLECT. 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 AMES GLUCOMETER REFLECT. PHOTOMETER?

The FDA product code for AMES GLUCOMETER REFLECT. PHOTOMETER is JJQ.

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Other records listing Miles Laboratories, 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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Related Devices (Code: JJQ)

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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