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FDA 510(k)

STATTEK-GLUCOSE LOW LEVEL

K-Number: K781075 · 1978-08-14

ApplicantBoehringer Mannheim Corp.
Decision Date1978-08-14
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

STATTEK-GLUCOSE LOW LEVEL 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 1978-08-14 under 510(k) number K781075. 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 STATTEK-GLUCOSE LOW LEVEL?

STATTEK-GLUCOSE LOW LEVEL is a medical device that received FDA 510(k) clearance on 1978-08-14. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K781075.

When did STATTEK-GLUCOSE LOW LEVEL receive FDA 510(k) clearance?

STATTEK-GLUCOSE LOW LEVEL received FDA 510(k) clearance on 1978-08-14, under 510(k) number K781075.

Who is the listed applicant for STATTEK-GLUCOSE LOW LEVEL?

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 STATTEK-GLUCOSE LOW LEVEL?

The FDA product code for STATTEK-GLUCOSE LOW LEVEL is CGA.

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Other records listing Boehringer Mannheim Corp. as applicant

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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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