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FDA 510(k)

25-HYDROXYVITAMIN D 125I RIA KIT

K-Number: K983617 · 1998-11-16

ApplicantDiaSorin, Inc.
Decision Date1998-11-16
Product CodeLCI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

25-HYDROXYVITAMIN D 125I RIA KIT is the device name listed in this FDA 510(k) record. The listed applicant is DiaSorin, Inc.. It received FDA 510(k) clearance on 1998-11-16 under 510(k) number K983617. The device is classified under product code LCI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 25-HYDROXYVITAMIN D 125I RIA KIT?

25-HYDROXYVITAMIN D 125I RIA KIT is a medical device that received FDA 510(k) clearance on 1998-11-16. The listed applicant is DiaSorin, Inc.. The 510(k) number is K983617.

When did 25-HYDROXYVITAMIN D 125I RIA KIT receive FDA 510(k) clearance?

25-HYDROXYVITAMIN D 125I RIA KIT received FDA 510(k) clearance on 1998-11-16, under 510(k) number K983617.

Who is the listed applicant for 25-HYDROXYVITAMIN D 125I RIA KIT?

The FDA 510(k) record lists DiaSorin, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 25-HYDROXYVITAMIN D 125I RIA KIT?

The FDA product code for 25-HYDROXYVITAMIN D 125I RIA KIT is LCI.

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Related Devices (Code: LCI)

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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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