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FDA 510(k)

GLUCOMETER ELITE LOW CONTROL

K-Number: K940577 · 1994-06-13

ApplicantHeraeus Kulzer, Inc.
Decision Date1994-06-13
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOMETER ELITE LOW CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Kulzer, Inc.. It received FDA 510(k) clearance on 1994-06-13 under 510(k) number K940577. 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 GLUCOMETER ELITE LOW CONTROL?

GLUCOMETER ELITE LOW CONTROL is a medical device that received FDA 510(k) clearance on 1994-06-13. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K940577.

When did GLUCOMETER ELITE LOW CONTROL receive FDA 510(k) clearance?

GLUCOMETER ELITE LOW CONTROL received FDA 510(k) clearance on 1994-06-13, under 510(k) number K940577.

Who is the listed applicant for GLUCOMETER ELITE LOW CONTROL?

The FDA 510(k) record lists Heraeus Kulzer, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GLUCOMETER ELITE LOW CONTROL?

The FDA product code for GLUCOMETER ELITE LOW CONTROL is JJX.

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Other records listing Heraeus Kulzer, Inc. as applicant

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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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