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FDA 510(k)

BOEHRINGER MANNHEIM DIAG. BLOOD GLUCOSE

K-Number: K842393 · 1984-08-16

ApplicantBoehringer Mannheim Corp.
Decision Date1984-08-16
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BOEHRINGER MANNHEIM DIAG. BLOOD GLUCOSE is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Mannheim Corp.. It received FDA 510(k) clearance on 1984-08-16 under 510(k) number K842393. 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 BOEHRINGER MANNHEIM DIAG. BLOOD GLUCOSE?

BOEHRINGER MANNHEIM DIAG. BLOOD GLUCOSE is a medical device that received FDA 510(k) clearance on 1984-08-16. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K842393.

When did BOEHRINGER MANNHEIM DIAG. BLOOD GLUCOSE receive FDA 510(k) clearance?

BOEHRINGER MANNHEIM DIAG. BLOOD GLUCOSE received FDA 510(k) clearance on 1984-08-16, under 510(k) number K842393.

Who is the listed applicant for BOEHRINGER MANNHEIM DIAG. BLOOD GLUCOSE?

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

What is the FDA product code for BOEHRINGER MANNHEIM DIAG. BLOOD GLUCOSE?

The FDA product code for BOEHRINGER MANNHEIM DIAG. BLOOD GLUCOSE 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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