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FDA 510(k)

GLUCOMETER QA BLOOD GLUCOSE MTR/GLUCOFILM TEST ST

K-Number: K893117 · 1989-06-16

ApplicantBayer Corp.
Decision Date1989-06-16
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOMETER QA BLOOD GLUCOSE MTR/GLUCOFILM TEST ST is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Corp.. It received FDA 510(k) clearance on 1989-06-16 under 510(k) number K893117. 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 QA BLOOD GLUCOSE MTR/GLUCOFILM TEST ST?

GLUCOMETER QA BLOOD GLUCOSE MTR/GLUCOFILM TEST ST is a medical device that received FDA 510(k) clearance on 1989-06-16. The listed applicant is Bayer Corp.. The 510(k) number is K893117.

When did GLUCOMETER QA BLOOD GLUCOSE MTR/GLUCOFILM TEST ST receive FDA 510(k) clearance?

GLUCOMETER QA BLOOD GLUCOSE MTR/GLUCOFILM TEST ST received FDA 510(k) clearance on 1989-06-16, under 510(k) number K893117.

Who is the listed applicant for GLUCOMETER QA BLOOD GLUCOSE MTR/GLUCOFILM TEST ST?

The FDA 510(k) record lists Bayer Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GLUCOMETER QA BLOOD GLUCOSE MTR/GLUCOFILM TEST ST?

The FDA product code for GLUCOMETER QA BLOOD GLUCOSE MTR/GLUCOFILM TEST ST is CGA.

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Other records listing Bayer Corp. 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: CGA)

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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