FDA 510(k)

APO A-I RIA KIT-HUMAN PLASMA APOLIP-

K-Number: K840105 · 1984-01-10

Decision Date1984-01-10

Product Code

DecisionUnknown

Device Summary

APO A-I RIA KIT-HUMAN PLASMA APOLIP- is the device name listed in this FDA 510(k) record. The listed applicant is Iso-Tex Diagnostics. It received FDA 510(k) clearance on 1984-01-10 under 510(k) number K840105. FDA Decision: Unknown.

Frequently Asked Questions

What is the APO A-I RIA KIT-HUMAN PLASMA APOLIP-?

APO A-I RIA KIT-HUMAN PLASMA APOLIP- is a medical device that received FDA 510(k) clearance on 1984-01-10. The listed applicant is Iso-Tex Diagnostics. The 510(k) number is K840105.

When did APO A-I RIA KIT-HUMAN PLASMA APOLIP- receive FDA 510(k) clearance?

APO A-I RIA KIT-HUMAN PLASMA APOLIP- received FDA 510(k) clearance on 1984-01-10, under 510(k) number K840105.

Who is the listed applicant for APO A-I RIA KIT-HUMAN PLASMA APOLIP-?

The FDA 510(k) record lists Iso-Tex Diagnostics as the applicant. This does not by itself establish the device manufacturer.

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Other records listing Iso-Tex Diagnostics as applicant

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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.