Cleared Traditional

RETIC CHEX LINEARITY

K000115 · Streck Laboratories, Inc. · Hematology
Mar 2000
Decision
73d
Days
Class 2
Risk

About This 510(k) Submission

K000115 is an FDA 510(k) clearance for the RETIC CHEX LINEARITY, a Mixture, Hematology Quality Control (Class II — Special Controls, product code JPK), submitted by Streck Laboratories, Inc. (Omaha, US). The FDA issued a Cleared decision on March 27, 2000, 73 days after receiving the submission on January 14, 2000. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K000115 FDA.gov
FDA Decision Cleared SESE
Date Received January 14, 2000
Decision Date March 27, 2000
Days to Decision 73 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code JPK — Mixture, Hematology Quality Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.8625