Cleared Traditional

API STAPHASE III

K833988 · Analytical Products, Inc. · Microbiology
Dec 1983
Decision
34d
Days
Class 1
Risk

About This 510(k) Submission

K833988 is an FDA 510(k) clearance for the API STAPHASE III, a Plasma, Coagulase, Human, Horse And Rabbit (Class I — General Controls, product code JTL), submitted by Analytical Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 22, 1983, 34 days after receiving the submission on November 18, 1983. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2160.

Submission Details

510(k) Number K833988 FDA.gov
FDA Decision Cleared SESE
Date Received November 18, 1983
Decision Date December 22, 1983
Days to Decision 34 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JTL — Plasma, Coagulase, Human, Horse And Rabbit
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2160

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