FDA 510(k)

ELECSYS CALCHECK CK-MB

K-Number: K963182 · 1996-08-23

Decision Date1996-08-23

Product CodeJJX

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

ELECSYS CALCHECK CK-MB 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 1996-08-23 under 510(k) number K963182. 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 ELECSYS CALCHECK CK-MB?

ELECSYS CALCHECK CK-MB is a medical device that received FDA 510(k) clearance on 1996-08-23. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K963182.

When did ELECSYS CALCHECK CK-MB receive FDA 510(k) clearance?

ELECSYS CALCHECK CK-MB received FDA 510(k) clearance on 1996-08-23, under 510(k) number K963182.

Who is the listed applicant for ELECSYS CALCHECK CK-MB?

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 ELECSYS CALCHECK CK-MB?

The FDA product code for ELECSYS CALCHECK CK-MB is JJX.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.