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FDA 510(k)

ELECSYS CALCHECK VITAMIN B12

K-Number: K974383 · 1997-12-08

ApplicantBoehringer Mannheim Corp.
Decision Date1997-12-08
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELECSYS CALCHECK VITAMIN B12 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 1997-12-08 under 510(k) number K974383. 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 VITAMIN B12?

ELECSYS CALCHECK VITAMIN B12 is a medical device that received FDA 510(k) clearance on 1997-12-08. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K974383.

When did ELECSYS CALCHECK VITAMIN B12 receive FDA 510(k) clearance?

ELECSYS CALCHECK VITAMIN B12 received FDA 510(k) clearance on 1997-12-08, under 510(k) number K974383.

Who is the listed applicant for ELECSYS CALCHECK VITAMIN B12?

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 VITAMIN B12?

The FDA product code for ELECSYS CALCHECK VITAMIN B12 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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