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FDA 510(k)

ELECSYS CALCHECK FT4

K-Number: K963164 · 1996-08-27

ApplicantBoehringer Mannheim Corp.
Decision Date1996-08-27
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELECSYS CALCHECK FT4 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 1996-08-27 under 510(k) number K963164. 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 FT4?

ELECSYS CALCHECK FT4 is a medical device that received FDA 510(k) clearance on 1996-08-27. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K963164.

When did ELECSYS CALCHECK FT4 receive FDA 510(k) clearance?

ELECSYS CALCHECK FT4 received FDA 510(k) clearance on 1996-08-27, under 510(k) number K963164.

Who is the listed applicant for ELECSYS CALCHECK FT4?

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 FT4?

The FDA product code for ELECSYS CALCHECK FT4 is JJX.

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Other records listing Boehringer Mannheim Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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