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

Cleared Feb 17, 1999

CBC-5D HEMATOLOGY CONTROL

K983032 · JPK

Hematology · 170d

Cleared Dec 10, 1998

QBC CENTRIFUGAL HEMATOLOGY CONTROL

K984099 · JPK

Hematology · 23d

Cleared Jul 20, 1998

STATUSFLOW

K982231 · GKZ

Hematology · 25d

Cleared Jul 24, 1997

ESR CONTROL-HC HEMATOLOGY ERYTHROCYTE SEDIMENTATION

K972170 · JPK

Hematology · 45d

Cleared Jul 24, 1997

ESR CONTROL-M HEMATOLOGY ERYTHROCYTE SEDIMENTATION

K972172 · JPK

Hematology · 45d

Cleared Apr 16, 1997

CBC-4K HEMATOLOGY CONTROL

K970331 · JPK

Hematology · 78d

Cleared Jul 15, 1996

R&D RETIC-PG HEMATOLOGY CONTROL

K961673 · JPK

Hematology · 75d

Cleared Jul 01, 1996

R & D SYSTEMS' WHOLE BLOOD FLOW CONTROL, (R & D - WBFC)

K961610 · GKZ

Hematology · 67d

Cleared Feb 29, 1996

CBC-CAL PLUS HEMATOLOGY CALIBRATOR

K955925 · KRX

Hematology · 69d

Cleared Oct 06, 1995

QBC CENTRIFUGAL HEMATOLOGY CONTROL

K954137 · JPK

Hematology · 35d

Cleared Dec 12, 1994

RETIC CONTROL-M HEMATOLOGY CONTROL/MULTIPLE

K943335 · JPK

Hematology · 153d

Cleared Dec 12, 1994

RETIC CONTROL-H HEMATOLOGY CONTROL/MULTIPLE

K943336 · JPK

Hematology · 153d

Cleared Oct 07, 1994

CBC-LINE HEMATOLOGY LINEARITY CONTROL

K942822 · JPK

Hematology · 114d

Cleared Jul 19, 1994

QUANTIKINE IVD ERYTHROPOIETIN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)

K936016 · GGT

Hematology · 215d

Cleared Apr 21, 1994

QUANTIKINE(TM) ERYTHROPOIETIN HUMAN SERUM CONTROLS

K931756 · GGT

Hematology · 378d

Cleared Mar 22, 1994

CBC-COBAS 5 HEMATOLOGY CONTROL/MULTIPLE

K940089 · JPK

Hematology · 74d

Cleared Dec 06, 1993

CBC-STK(TM) HEMATOLOGY CONTROL/MULTIPLE

K934497 · JCN

Hematology · 83d

Cleared Jul 20, 1993

QUANTIKINE(TM) ERYTHROPOIETIN/ENZ LINK IMMUN ASSAY

K931666 · GGT

Hematology · 105d

Cleared Nov 27, 1991

CBC-8K(TM) HEMATOLOGY CONTROL/MULTIPLE

K913879 · JPK

Hematology · 90d

Cleared Jul 09, 1991

3K-CAL HEMATOLOGY CALIBRATOR/MULTIPLE

K912357 · KRX

Hematology · 42d

Cleared Oct 29, 1990

QBC(R) CENTRIFUGAL HEMATOLOGY CONTROL/MULTIPLE

K904637 · JPK

Hematology · 18d

Cleared Oct 23, 1990

CBC-LASER(R) HEMATOLOGY CONTROL/MULTIPLE-MODIFIED

K904464 · JPK

Hematology · 22d

Cleared Jan 02, 1990

CBC-CAL(TM) PLUS HEMATOLOGY CALIBRATOR/MULTIPLE

K897060 · KSA

Hematology · 15d

Cleared Aug 15, 1989

HGB-CAL SET/MULTIPLE

K893984 · KRZ

Hematology · 71d

Cleared Aug 15, 1989

HGB-CONTROL SET/MULTIPLE

K893985 · GGM

Hematology · 71d