Cleared Traditional

UNITIZED HEMATOLOGY SET 65132/93

K840477 · Emd Chemicals, Inc. · Hematology
Mar 1984
Decision
31d
Days
Class 1
Risk

About This 510(k) Submission

K840477 is an FDA 510(k) clearance for the UNITIZED HEMATOLOGY SET 65132/93, a Diluent, Blood Cell (Class I — General Controls, product code GIF), submitted by Emd Chemicals, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 5, 1984, 31 days after receiving the submission on February 3, 1984. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8200.

Submission Details

510(k) Number K840477 FDA.gov
FDA Decision Cleared SESE
Date Received February 03, 1984
Decision Date March 05, 1984
Days to Decision 31 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code GIF — Diluent, Blood Cell
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.8200

Similar Devices — GIF Diluent, Blood Cell

All 37
KVM ISOTONIC FLUSH SOLUTION
K883989 · Kvm Technologies, Inc. · Oct 1988
KVM ISOTONIC DILUENT
K883990 · Kvm Technologies, Inc. · Oct 1988
HYCEL QUICK-LYSING HEMOGLOBIN REAGENT
K882490 · R&D Systems, Inc. · Jul 1988
SYSMEX QUICKLYSER-II (QLS-200A)
K882267 · Toa Medical Electronics USA, Inc. · Jul 1988
CELL-DYN ISOTONIC DILUENT
K881130 · Abbott Diagnostics · Mar 1988
CELL-DYN DIFF. SCREEN ISOTONIC DILUENT
K873347 · Abbott Diagnostics · Sep 1987