R&D Systems, Inc. - FDA 510(k) Cleared Devices
79
Total
79
Cleared
0
Denied
74 devices
Cleared
Apr 11, 1989
QBC(R) CENTRIFUGAL HEMATOLOGY CONTR/MULTI MODIFIED
Hematology
15d
Cleared
Feb 27, 1989
CBC-TECH (TM) HEMATOLOGY CONTROL/MULTIPLE
Hematology
14d
Cleared
Jul 25, 1988
HYCEL QUICK-LYSING HEMOGLOBIN REAGENT
Hematology
39d
Cleared
May 02, 1988
TECH-CAL(TM)/MULTIPLE
Hematology
45d
Cleared
Dec 30, 1987
CBC-TECH(TM) HEMATOLOGY CONTROL/MULTIPLE
Hematology
65d
Cleared
Sep 29, 1987
QBC VENOUS BLOOD CONTROL/MULTIPLE
Hematology
40d
Cleared
Aug 21, 1986
CBC-CAL (TM) PLUS/MULTIPLE
Hematology
23d
Cleared
Feb 13, 1986
CBC-CAL/MULTIPLE
Hematology
72d
Cleared
Nov 26, 1985
PLATELET-TROL II
Hematology
29d
Cleared
Jul 09, 1985
LASER PLATELETCAL/MULTIPLE
Hematology
61d
Cleared
May 13, 1985
CBC-PLT-4/MULTIPLE WHOLE BLOOD HEMATOLOGY CONTROL
Hematology
77d
Cleared
Nov 01, 1984
CBC-PLT-4 WHOLE BLOOD CONTROL/MULTIPLE
Hematology
21d
Cleared
Oct 30, 1984
RETIC-SET
Hematology
46d
Cleared
Oct 01, 1984
HYCEL DILUTOR, VARIOUS MODELS/MULTI
Hematology
80d
Cleared
Aug 17, 1984
HYCEL ROTOR-MIXER AND/OR MULTI
Hematology
35d
Cleared
May 31, 1984
RETIC-SET
Hematology
64d
Cleared
May 02, 1984
CELLTRAK-B
Hematology
125d
Cleared
Mar 12, 1984
PLT - 4 PLATELET
Hematology
48d
Cleared
Jun 02, 1982
RETIC SET
Hematology
29d
Cleared
Dec 31, 1980
CRC(CYANMETHEMOGLOBIN REAGENT CONCENT
Hematology
106d
Cleared
Nov 12, 1980
CBC PLT-4
Hematology
57d
Cleared
Nov 12, 1980
PLT-4 SIZE-CHECK
Hematology
57d
Cleared
Oct 23, 1980
HGB3 (1:251)
Hematology
37d
Cleared
Feb 03, 1978
HEMATOLOGY REFERENCE CONTROLS
Hematology
67d