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."
1–24 of 79
Search insights Median review: 50d Cleared: 100% Top manufacturer: R&D Systems, Inc. Lead specialty: Hematology
Cleared Sep 01, 2016
BC-5D Hematology Control
K160606 · JPK
R&D Systems, Inc.
Hematology · 183d
Cleared Jul 24, 2013
R&D 5D RETIC HEMATOLOGY CONTROL
K130962 · JPK
R&D Systems, Inc.
Hematology · 107d
Cleared Apr 28, 2011
R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL
K101578 · JPK
R&D Systems, Inc.
Hematology · 325d
Cleared Jan 29, 2010
R & D SYSTEMS XERET HEMATOLOGY CONTROL
K100050 · JPK
R&D Systems, Inc.
Hematology · 21d
Cleared Oct 28, 2009
R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROL
K091433 · JPK
R&D Systems, Inc.
Hematology · 168d
Cleared Dec 27, 2007
HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004
K073178 · JPK
R&D Systems, Inc.
Hematology · 44d
Cleared Nov 26, 2007
CSF AUTOMATED CONTROL, MODELS CSF001, CSF003
K072846 · JPK
R&D Systems, Inc.
Hematology · 53d
Cleared Nov 20, 2007
HC WBC HEMATOLOGY CONTROL, MODEL: WBC00S
K072268 · JPK
R&D Systems, Inc.
Hematology · 97d
Cleared Aug 20, 2007
CBC-5D PLUS RETICS HEMATOLOGY CONTROL, MODELS: 5DR03, 5DR04
K072096 · JPK
R&D Systems, Inc.
Hematology · 20d
Cleared Mar 29, 2007
R&D SICKLE QC CONTROL
K070334 · GGM
R&D Systems, Inc.
Hematology · 52d
Cleared Jul 10, 2006
R&D CBC-3D + CRP HEMATOLOGY CONTROL
K061511 · JPK
R&D Systems, Inc.
Hematology · 39d
Cleared Jun 02, 2006
R&D LH-NRBC HEMATOLOGY CONTROL
K061320 · JPK
R&D Systems, Inc.
Hematology · 22d
Cleared Jul 12, 2005
R&D CBC-4K PLUS RETICS HEMATOLOGY CONTROL
K051339 · JPK
R&D Systems, Inc.
Hematology · 50d
Cleared Sep 01, 2004
R&D CBC-XE HEMATOLOGY CONTROL
K042094 · JPK
R&D Systems, Inc.
Hematology · 29d
Cleared Mar 10, 2004
R&D GLU-LINE HEMATOLOGY CONTROL
K034048 · JJX
R&D Systems, Inc.
Chemistry · 71d
Cleared Feb 06, 2002
R & D BODY FLUID CONTROL
K020229 · JPK
R&D Systems, Inc.
Hematology · 14d
Cleared Jan 22, 2002
R&D RET-LINE KIT
K013898 · JPK
R&D Systems, Inc.
Hematology · 60d
Cleared May 11, 2001
R & D 4K RETIC
K010470 · JPK
R&D Systems, Inc.
Hematology · 80d
Cleared Apr 03, 2001
ADVIA RETIC PLUS
K010461 · JPK
R&D Systems, Inc.
Hematology · 46d
Cleared Mar 16, 2001
CBC-SF
K010409 · JPK
R&D Systems, Inc.
Hematology · 32d
Cleared Jan 16, 2001
CD-CAL PLUS CALIBRATOR
K003991 · KRX
R&D Systems, Inc.
Hematology · 21d
Cleared Jan 12, 2001
CBC-4K HEMATOLOGY CONTROL
K003874 · JPK
R&D Systems, Inc.
Hematology · 28d
Cleared Dec 01, 2000
PENTRA 5D
K003534 · JPK
R&D Systems, Inc.
Hematology · 15d
Cleared Nov 07, 2000
R & D 3K RETIC
K003208 · JPK
R&D Systems, Inc.
Hematology · 25d