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FDA 510(k)

THE ELECSYS CALCHECK PROGESTERONE

K-Number: K970984 · 1997-04-02

ApplicantBoehringer Mannheim Corp.
Decision Date1997-04-02
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

THE ELECSYS CALCHECK PROGESTERONE 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 1997-04-02 under 510(k) number K970984. 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 THE ELECSYS CALCHECK PROGESTERONE?

THE ELECSYS CALCHECK PROGESTERONE is a medical device that received FDA 510(k) clearance on 1997-04-02. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K970984.

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

THE ELECSYS CALCHECK PROGESTERONE received FDA 510(k) clearance on 1997-04-02, under 510(k) number K970984.

Who is the listed applicant for THE ELECSYS CALCHECK PROGESTERONE?

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 THE ELECSYS CALCHECK PROGESTERONE?

The FDA product code for THE ELECSYS CALCHECK PROGESTERONE is JJX.

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Other records listing Boehringer Mannheim Corp. 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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