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FDA 510(k)

ELECSYS FOLATE II CALSET II

K-Number: K042490 · 2004-09-30

ApplicantRoche Diagnostics Corp.
Decision Date2004-09-30
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELECSYS FOLATE II 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 2004-09-30 under 510(k) number K042490. 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 FOLATE II CALSET II?

ELECSYS FOLATE II CALSET II is a medical device that received FDA 510(k) clearance on 2004-09-30. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K042490.

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

ELECSYS FOLATE II CALSET II received FDA 510(k) clearance on 2004-09-30, under 510(k) number K042490.

Who is the listed applicant for ELECSYS FOLATE II 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 FOLATE II CALSET II?

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

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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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