Cleared Traditional

CELL-DYN RAPID-LYSE AND HEMOGLOBLIN

K881242 · Abbott Diagnostics · Hematology
Apr 1988
Decision
36d
Days
Class 2
Risk

About This 510(k) Submission

K881242 is an FDA 510(k) clearance for the CELL-DYN RAPID-LYSE AND HEMOGLOBLIN, a Cyanomethemoglobin Reagent And Standard Solution (Class II — Special Controls, product code GJZ), submitted by Abbott Diagnostics (Mountain View, US). The FDA issued a Cleared decision on April 21, 1988, 36 days after receiving the submission on March 16, 1988. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7500.

Submission Details

510(k) Number K881242 FDA.gov
FDA Decision Cleared SESE
Date Received March 16, 1988
Decision Date April 21, 1988
Days to Decision 36 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code GJZ — Cyanomethemoglobin Reagent And Standard Solution
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7500