Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

79 results for "R&D Systems, Inc."
25–48 of 79
Search insights Median review: 50d Cleared: 100% Top manufacturer: R&D Systems, Inc. Lead specialty: Hematology
Cleared Nov 12, 1999
R&D HGB/GLC WHOLE BLOOD CONTROL
K993321 · GGM
R&D Systems, Inc.
Hematology · 39d
Cleared Jun 17, 1999
SEDRITE PLUS ERYTHROCYTE SEDIMENTATION RATE
K991876 · JPK
R&D Systems, Inc.
Hematology · 15d
Cleared Feb 17, 1999
CBC-5D HEMATOLOGY CONTROL
K983032 · JPK
R&D Systems, Inc.
Hematology · 170d
Cleared Dec 10, 1998
QBC CENTRIFUGAL HEMATOLOGY CONTROL
K984099 · JPK
R&D Systems, Inc.
Hematology · 23d
Cleared Jul 20, 1998
STATUSFLOW
K982231 · GKZ
R&D Systems, Inc.
Hematology · 25d
Cleared Jul 24, 1997
ESR CONTROL-M HEMATOLOGY ERYTHROCYTE SEDIMENTATION
K972172 · JPK
R&D Systems, Inc.
Hematology · 45d
Cleared Jul 24, 1997
ESR CONTROL-HC HEMATOLOGY ERYTHROCYTE SEDIMENTATION
K972170 · JPK
R&D Systems, Inc.
Hematology · 45d
Cleared May 29, 1997
QUANTIKINE IVD BETA-2-MICROGLOBULIN ENZYME IMMUNOASSAY (EIA(
K964767 · JZG
R&D Systems, Inc.
Immunology · 183d
Cleared May 27, 1997
QUANTIKINE IVD STFR ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)
K970718 · JNM
R&D Systems, Inc.
Immunology · 90d
Cleared Apr 16, 1997
CBC-4K HEMATOLOGY CONTROL
K970331 · JPK
R&D Systems, Inc.
Hematology · 78d
Cleared Jul 15, 1996
R&D RETIC-PG HEMATOLOGY CONTROL
K961673 · JPK
R&D Systems, Inc.
Hematology · 75d
Cleared Jul 01, 1996
R & D SYSTEMS' WHOLE BLOOD FLOW CONTROL, (R & D - WBFC)
K961610 · GKZ
R&D Systems, Inc.
Hematology · 67d
Cleared Feb 29, 1996
CBC-CAL PLUS HEMATOLOGY CALIBRATOR
K955925 · KRX
R&D Systems, Inc.
Hematology · 69d
Cleared Oct 06, 1995
QBC CENTRIFUGAL HEMATOLOGY CONTROL
K954137 · JPK
R&D Systems, Inc.
Hematology · 35d
Cleared Dec 12, 1994
RETIC CONTROL-H HEMATOLOGY CONTROL/MULTIPLE
K943336 · JPK
R&D Systems, Inc.
Hematology · 153d
Cleared Dec 12, 1994
RETIC CONTROL-M HEMATOLOGY CONTROL/MULTIPLE
K943335 · JPK
R&D Systems, Inc.
Hematology · 153d
Cleared Oct 07, 1994
CBC-LINE HEMATOLOGY LINEARITY CONTROL
K942822 · JPK
R&D Systems, Inc.
Hematology · 114d
Cleared Jul 19, 1994
QUANTIKINE IVD ERYTHROPOIETIN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)
K936016 · GGT
R&D Systems, Inc.
Hematology · 215d
Cleared Apr 21, 1994
QUANTIKINE(TM) ERYTHROPOIETIN HUMAN SERUM CONTROLS
K931756 · GGT
R&D Systems, Inc.
Hematology · 378d
Cleared Mar 22, 1994
CBC-COBAS 5 HEMATOLOGY CONTROL/MULTIPLE
K940089 · JPK
R&D Systems, Inc.
Hematology · 74d
Cleared Dec 06, 1993
CBC-STK(TM) HEMATOLOGY CONTROL/MULTIPLE
K934497 · JCN
R&D Systems, Inc.
Hematology · 83d
Cleared Jul 20, 1993
QUANTIKINE(TM) ERYTHROPOIETIN/ENZ LINK IMMUN ASSAY
K931666 · GGT
R&D Systems, Inc.
Hematology · 105d
Cleared Nov 27, 1991
CBC-8K(TM) HEMATOLOGY CONTROL/MULTIPLE
K913879 · JPK
R&D Systems, Inc.
Hematology · 90d
Cleared Jul 09, 1991
3K-CAL HEMATOLOGY CALIBRATOR/MULTIPLE
K912357 · KRX
R&D Systems, Inc.
Hematology · 42d