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FDA 510(k)

ELECSYS CALCHECK TESTOSTERONE

K-Number: K970146 · 1997-01-30

ApplicantBoehringer Mannheim Corp.
Decision Date1997-01-30
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELECSYS CALCHECK TESTOSTERONE 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 1997-01-30 under 510(k) number K970146. 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 TESTOSTERONE?

ELECSYS CALCHECK TESTOSTERONE is a medical device that received FDA 510(k) clearance on 1997-01-30. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K970146.

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

ELECSYS CALCHECK TESTOSTERONE received FDA 510(k) clearance on 1997-01-30, under 510(k) number K970146.

Who is the listed applicant for ELECSYS CALCHECK TESTOSTERONE?

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 TESTOSTERONE?

The FDA product code for ELECSYS CALCHECK TESTOSTERONE 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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