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FDA 510(k)

ACCU-CHEK II LOW AND HIGH GLUCOSE CONTROL

K-Number: K855225 · 1986-01-17

ApplicantBoehringer Mannheim Corp.
Decision Date1986-01-17
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACCU-CHEK II LOW AND HIGH GLUCOSE CONTROL 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 1986-01-17 under 510(k) number K855225. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCU-CHEK II LOW AND HIGH GLUCOSE CONTROL?

ACCU-CHEK II LOW AND HIGH GLUCOSE CONTROL is a medical device that received FDA 510(k) clearance on 1986-01-17. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K855225.

When did ACCU-CHEK II LOW AND HIGH GLUCOSE CONTROL receive FDA 510(k) clearance?

ACCU-CHEK II LOW AND HIGH GLUCOSE CONTROL received FDA 510(k) clearance on 1986-01-17, under 510(k) number K855225.

Who is the listed applicant for ACCU-CHEK II LOW AND HIGH GLUCOSE CONTROL?

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 ACCU-CHEK II LOW AND HIGH GLUCOSE CONTROL?

The FDA product code for ACCU-CHEK II LOW AND HIGH GLUCOSE CONTROL is JJX.

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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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