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

79 devices

51-75 of 79

Cleared Jan 02, 1990

CBC-CAL(TM) PLUS HEMATOLOGY CALIBRATOR/MULTIPLE

Hematology · 15d

Cleared Aug 15, 1989

HGB-CAL SET/MULTIPLE

Hematology · 71d

Cleared Aug 15, 1989

HGB-CONTROL SET/MULTIPLE

Hematology · 71d

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

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

Hematology · 64d

Cleared May 02, 1984

Hematology · 125d

Cleared Mar 12, 1984

PLT - 4 PLATELET

Hematology · 48d

Cleared Aug 16, 1983

MASSAGE TABLE AAT-100

Physical Medicine · 21d

Cleared Jun 08, 1983

SPIA SYS FOR SOLID PHASE IMMUNOASSAYS

Chemistry · 34d

Cleared Jun 02, 1982

Hematology · 29d

Cleared Dec 31, 1980

CRC(CYANMETHEMOGLOBIN REAGENT CONCENT

Hematology · 106d

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