Cleared Traditional

HEMACOUNT WRIGHT GIEMSA STAIN PACK

K822602 · Accra Laboratories, Inc. · Pathology
Sep 1982
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K822602 is an FDA 510(k) clearance for the HEMACOUNT WRIGHT GIEMSA STAIN PACK, a Monitor, Ultrasonic, Nonfetal (Class II — Special Controls, product code JAF), submitted by Accra Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 17, 1982, 21 days after receiving the submission on August 27, 1982. This device falls under the Pathology review panel. Regulated under 21 CFR 892.1540.

Submission Details

510(k) Number K822602 FDA.gov
FDA Decision Cleared SESE
Date Received August 27, 1982
Decision Date September 17, 1982
Days to Decision 21 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code JAF — Monitor, Ultrasonic, Nonfetal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1540