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FDA 510(k)

TWIN BUN/GLUCOSE

K-Number: K861775 · 1986-06-27

ApplicantBoehringer Mannheim Corp.
Decision Date1986-06-27
Product CodeCDW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TWIN BUN/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 1986-06-27 under 510(k) number K861775. The device is classified under product code CDW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TWIN BUN/GLUCOSE?

TWIN BUN/GLUCOSE is a medical device that received FDA 510(k) clearance on 1986-06-27. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K861775.

When did TWIN BUN/GLUCOSE receive FDA 510(k) clearance?

TWIN BUN/GLUCOSE received FDA 510(k) clearance on 1986-06-27, under 510(k) number K861775.

Who is the listed applicant for TWIN BUN/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 TWIN BUN/GLUCOSE?

The FDA product code for TWIN BUN/GLUCOSE is CDW.

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Other records listing Boehringer Mannheim Corp. as applicant

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Related Devices (Code: CDW)

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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