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FDA 510(k)

ELECSYS HCG+B CALCHECK

K-Number: K010237 · 2001-02-14

ApplicantRoche Diagnostics Corp.
Decision Date2001-02-14
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELECSYS HCG+B CALCHECK is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Corp.. It received FDA 510(k) clearance on 2001-02-14 under 510(k) number K010237. 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 HCG+B CALCHECK?

ELECSYS HCG+B CALCHECK is a medical device that received FDA 510(k) clearance on 2001-02-14. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K010237.

When did ELECSYS HCG+B CALCHECK receive FDA 510(k) clearance?

ELECSYS HCG+B CALCHECK received FDA 510(k) clearance on 2001-02-14, under 510(k) number K010237.

Who is the listed applicant for ELECSYS HCG+B CALCHECK?

The FDA 510(k) record lists Roche Diagnostics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELECSYS HCG+B CALCHECK?

The FDA product code for ELECSYS HCG+B CALCHECK 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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