FDA 510(k)

ASO/CRP/RF CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS

K-Number: K983241 · 1998-09-29

Decision Date1998-09-29

Product CodeJJY

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

ASO/CRP/RF CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS is the device name listed in this FDA 510(k) record. The listed applicant is Kamiya Biomedical Co.. It received FDA 510(k) clearance on 1998-09-29 under 510(k) number K983241. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASO/CRP/RF CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS?

ASO/CRP/RF CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS is a medical device that received FDA 510(k) clearance on 1998-09-29. The listed applicant is Kamiya Biomedical Co.. The 510(k) number is K983241.

When did ASO/CRP/RF CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS receive FDA 510(k) clearance?

ASO/CRP/RF CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS received FDA 510(k) clearance on 1998-09-29, under 510(k) number K983241.

Who is the listed applicant for ASO/CRP/RF CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS?

The FDA 510(k) record lists Kamiya Biomedical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ASO/CRP/RF CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS?

The FDA product code for ASO/CRP/RF CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS is JJY.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.