Cleared Traditional

CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG.

K873348 · Abbott Diagnostics · Hematology
Sep 1987
Decision
20d
Days
Class 1
Risk

About This 510(k) Submission

K873348 is an FDA 510(k) clearance for the CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG., a Products, Red-cell Lysing Products (Class I — General Controls, product code GGK), submitted by Abbott Diagnostics (Mountain View, US). The FDA issued a Cleared decision on September 9, 1987, 20 days after receiving the submission on August 20, 1987. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8540.

Submission Details

510(k) Number K873348 FDA.gov
FDA Decision Cleared SESE
Date Received August 20, 1987
Decision Date September 09, 1987
Days to Decision 20 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code GGK — Products, Red-cell Lysing Products
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.8540