Cleared Traditional

PARA 12 PLUS

K901875 · Streck Laboratories, Inc. · Hematology
May 1990
Decision
34d
Days
Class 2
Risk

About This 510(k) Submission

K901875 is an FDA 510(k) clearance for the PARA 12 PLUS, a Control, Cell Counter, Normal And Abnormal (Class II — Special Controls, product code JCN), submitted by Streck Laboratories, Inc. (Omaha, US). The FDA issued a Cleared decision on May 30, 1990, 34 days after receiving the submission on April 26, 1990. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K901875 FDA.gov
FDA Decision Cleared SESE
Date Received April 26, 1990
Decision Date May 30, 1990
Days to Decision 34 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code JCN — Control, Cell Counter, Normal And Abnormal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.8625