Medical Device Manufacturer · US , Mchenry , IL

R&D Systems, Inc. - FDA 510(k) Cleared Devices

79 submissions · 79 cleared · Since 1978
79
Total
79
Cleared
0
Denied
74 devices
51-74 of 74
Cleared Apr 11, 1989
QBC(R) CENTRIFUGAL HEMATOLOGY CONTR/MULTI MODIFIED
K891907 · JCN
Hematology · 15d
Cleared Feb 27, 1989
CBC-TECH (TM) HEMATOLOGY CONTROL/MULTIPLE
K890749 · JPK
Hematology · 14d
Cleared Jul 25, 1988
HYCEL QUICK-LYSING HEMOGLOBIN REAGENT
K882490 · GIF
Hematology · 39d
Cleared May 02, 1988
TECH-CAL(TM)/MULTIPLE
K881161 · KSA
Hematology · 45d
Cleared Dec 30, 1987
CBC-TECH(TM) HEMATOLOGY CONTROL/MULTIPLE
K874386 · JCN
Hematology · 65d
Cleared Sep 29, 1987
QBC VENOUS BLOOD CONTROL/MULTIPLE
K873354 · JPK
Hematology · 40d
Cleared Aug 21, 1986
CBC-CAL (TM) PLUS/MULTIPLE
K862858 · KRX
Hematology · 23d
Cleared Feb 13, 1986
CBC-CAL/MULTIPLE
K854823 · KSA
Hematology · 72d
Cleared Nov 26, 1985
PLATELET-TROL II
K854353 · JPK
Hematology · 29d
Cleared Jul 09, 1985
LASER PLATELETCAL/MULTIPLE
K852016 · KRY
Hematology · 61d
Cleared May 13, 1985
CBC-PLT-4/MULTIPLE WHOLE BLOOD HEMATOLOGY CONTROL
K850755 · JPK
Hematology · 77d
Cleared Nov 01, 1984
CBC-PLT-4 WHOLE BLOOD CONTROL/MULTIPLE
K843962 · JPK
Hematology · 21d
Cleared Oct 30, 1984
RETIC-SET
K843619 · KQC
Hematology · 46d
Cleared Oct 01, 1984
HYCEL DILUTOR, VARIOUS MODELS/MULTI
K842747 · GKH
Hematology · 80d
Cleared Aug 17, 1984
HYCEL ROTOR-MIXER AND/OR MULTI
K842746 · KSQ
Hematology · 35d
Cleared May 31, 1984
RETIC-SET
K841848 · KQC
Hematology · 64d
Cleared May 02, 1984
CELLTRAK-B
K834585 · FRZ
Hematology · 125d
Cleared Mar 12, 1984
PLT - 4 PLATELET
K840302 · JPK
Hematology · 48d
Cleared Jun 02, 1982
RETIC SET
K821318 · KJN
Hematology · 29d
Cleared Dec 31, 1980
CRC(CYANMETHEMOGLOBIN REAGENT CONCENT
K802268 · KHG
Hematology · 106d
Cleared Nov 12, 1980
CBC PLT-4
K802265 · JPK
Hematology · 57d
Cleared Nov 12, 1980
PLT-4 SIZE-CHECK
K802267 · JPK
Hematology · 57d
Cleared Oct 23, 1980
HGB3 (1:251)
K802266 · GKR
Hematology · 37d
Cleared Feb 03, 1978
HEMATOLOGY REFERENCE CONTROLS
K772195 · JPK
Hematology · 67d
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