Cleared Traditional

RET-CHECK

K900484 · Streck Laboratories, Inc. · Hematology
Mar 1990
Decision
36d
Days
Class 2
Risk

About This 510(k) Submission

K900484 is an FDA 510(k) clearance for the RET-CHECK, a Control, Red-cell (Class II — Special Controls, product code GJR), submitted by Streck Laboratories, Inc. (Omaha, US). The FDA issued a Cleared decision on March 9, 1990, 36 days after receiving the submission on February 1, 1990. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K900484 FDA.gov
FDA Decision Cleared SESE
Date Received February 01, 1990
Decision Date March 09, 1990
Days to Decision 36 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code GJR — Control, Red-cell
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.8625