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FDA 510(k)

ELECSYS ESTRADIOL CALSET II

K-Number: K992981 · 1999-09-24

ApplicantRoche Diagnostics Corp.
Decision Date1999-09-24
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELECSYS ESTRADIOL CALSET II 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 1999-09-24 under 510(k) number K992981. The device is classified under product code JIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECSYS ESTRADIOL CALSET II?

ELECSYS ESTRADIOL CALSET II is a medical device that received FDA 510(k) clearance on 1999-09-24. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K992981.

When did ELECSYS ESTRADIOL CALSET II receive FDA 510(k) clearance?

ELECSYS ESTRADIOL CALSET II received FDA 510(k) clearance on 1999-09-24, under 510(k) number K992981.

Who is the listed applicant for ELECSYS ESTRADIOL CALSET II?

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 ESTRADIOL CALSET II?

The FDA product code for ELECSYS ESTRADIOL CALSET II is JIT.

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Other records listing Roche Diagnostics 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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