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FDA 510(k)

BLOOD GLUCOSE TESTER

K-Number: K801536 · 1980-09-16

ApplicantBroomer Research Corp.
Decision Date1980-09-16
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BLOOD GLUCOSE TESTER is the device name listed in this FDA 510(k) record. The listed applicant is Broomer Research Corp.. It received FDA 510(k) clearance on 1980-09-16 under 510(k) number K801536. 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 BLOOD GLUCOSE TESTER?

BLOOD GLUCOSE TESTER is a medical device that received FDA 510(k) clearance on 1980-09-16. The listed applicant is Broomer Research Corp.. The 510(k) number is K801536.

When did BLOOD GLUCOSE TESTER receive FDA 510(k) clearance?

BLOOD GLUCOSE TESTER received FDA 510(k) clearance on 1980-09-16, under 510(k) number K801536.

Who is the listed applicant for BLOOD GLUCOSE TESTER?

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

What is the FDA product code for BLOOD GLUCOSE TESTER?

The FDA product code for BLOOD GLUCOSE TESTER is JJQ.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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