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FDA 510(k)

GAMMA-B 25-HYDROXY VITAMIN D RIA

K-Number: K991998 · 1999-09-17

ApplicantImmunodiagnostic Systems , Ltd.
Decision Date1999-09-17
Product CodeMRG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GAMMA-B 25-HYDROXY VITAMIN D RIA is the device name listed in this FDA 510(k) record. The listed applicant is Immunodiagnostic Systems , Ltd.. It received FDA 510(k) clearance on 1999-09-17 under 510(k) number K991998. The device is classified under product code MRG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAMMA-B 25-HYDROXY VITAMIN D RIA?

GAMMA-B 25-HYDROXY VITAMIN D RIA is a medical device that received FDA 510(k) clearance on 1999-09-17. The listed applicant is Immunodiagnostic Systems , Ltd.. The 510(k) number is K991998.

When did GAMMA-B 25-HYDROXY VITAMIN D RIA receive FDA 510(k) clearance?

GAMMA-B 25-HYDROXY VITAMIN D RIA received FDA 510(k) clearance on 1999-09-17, under 510(k) number K991998.

Who is the listed applicant for GAMMA-B 25-HYDROXY VITAMIN D RIA?

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

What is the FDA product code for GAMMA-B 25-HYDROXY VITAMIN D RIA?

The FDA product code for GAMMA-B 25-HYDROXY VITAMIN D RIA is MRG.

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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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