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FDA 510(k)

TRACER(TM) II BLOOD GLUCOSE SYSTEM

K-Number: K881908 · 1988-07-12

ApplicantBoehringer Mannheim Corp.
Decision Date1988-07-12
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TRACER(TM) II BLOOD GLUCOSE SYSTEM 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 1988-07-12 under 510(k) number K881908. 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 TRACER(TM) II BLOOD GLUCOSE SYSTEM?

TRACER(TM) II BLOOD GLUCOSE SYSTEM is a medical device that received FDA 510(k) clearance on 1988-07-12. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K881908.

When did TRACER(TM) II BLOOD GLUCOSE SYSTEM receive FDA 510(k) clearance?

TRACER(TM) II BLOOD GLUCOSE SYSTEM received FDA 510(k) clearance on 1988-07-12, under 510(k) number K881908.

Who is the listed applicant for TRACER(TM) II BLOOD GLUCOSE SYSTEM?

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 TRACER(TM) II BLOOD GLUCOSE SYSTEM?

The FDA product code for TRACER(TM) II BLOOD GLUCOSE SYSTEM is CGA.

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Other records listing Boehringer Mannheim 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)

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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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