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FDA 510(k)

ELECSYS CALCHECK PSA

K-Number: K970458 · 1997-03-06

ApplicantBoehringer Mannheim Corp.
Decision Date1997-03-06
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELECSYS CALCHECK PSA 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 1997-03-06 under 510(k) number K970458. 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 PSA?

ELECSYS CALCHECK PSA is a medical device that received FDA 510(k) clearance on 1997-03-06. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K970458.

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

ELECSYS CALCHECK PSA received FDA 510(k) clearance on 1997-03-06, under 510(k) number K970458.

Who is the listed applicant for ELECSYS CALCHECK PSA?

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 PSA?

The FDA product code for ELECSYS CALCHECK PSA 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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