Cleared Traditional

MMH PTH RIA KIT

K830700 · Diagnostic Systems · Chemistry
Apr 1983
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K830700 is an FDA 510(k) clearance for the MMH PTH RIA KIT, a Radioimmunoassay, Parathyroid Hormone (Class II — Special Controls, product code CEW), submitted by Diagnostic Systems (Mchenry, US). The FDA issued a Cleared decision on April 6, 1983, 30 days after receiving the submission on March 7, 1983. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1545.

Submission Details

510(k) Number K830700 FDA.gov
FDA Decision Cleared SESE
Date Received March 07, 1983
Decision Date April 06, 1983
Days to Decision 30 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CEW — Radioimmunoassay, Parathyroid Hormone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1545

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