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."
49–72 of 79
Search insights Median review: 50d Cleared: 100% Top manufacturer: R&D Systems, Inc. Lead specialty: Hematology
Cleared Oct 29, 1990
QBC(R) CENTRIFUGAL HEMATOLOGY CONTROL/MULTIPLE
K904637 · JPK
R&D Systems, Inc.
Hematology · 18d
Cleared Oct 23, 1990
CBC-LASER(R) HEMATOLOGY CONTROL/MULTIPLE-MODIFIED
K904464 · JPK
R&D Systems, Inc.
Hematology · 22d
Cleared Jan 02, 1990
CBC-CAL(TM) PLUS HEMATOLOGY CALIBRATOR/MULTIPLE
K897060 · KSA
R&D Systems, Inc.
Hematology · 15d
Cleared Aug 15, 1989
HGB-CONTROL SET/MULTIPLE
K893985 · GGM
R&D Systems, Inc.
Hematology · 71d
Cleared Aug 15, 1989
HGB-CAL SET/MULTIPLE
K893984 · KRZ
R&D Systems, Inc.
Hematology · 71d
Cleared Apr 11, 1989
QBC(R) CENTRIFUGAL HEMATOLOGY CONTR/MULTI MODIFIED
K891907 · JCN
R&D Systems, Inc.
Hematology · 15d
Cleared Feb 27, 1989
CBC-TECH (TM) HEMATOLOGY CONTROL/MULTIPLE
K890749 · JPK
R&D Systems, Inc.
Hematology · 14d
Cleared Jul 25, 1988
HYCEL QUICK-LYSING HEMOGLOBIN REAGENT
K882490 · GIF
R&D Systems, Inc.
Hematology · 39d
Cleared May 02, 1988
TECH-CAL(TM)/MULTIPLE
K881161 · KSA
R&D Systems, Inc.
Hematology · 45d
Cleared Dec 30, 1987
CBC-TECH(TM) HEMATOLOGY CONTROL/MULTIPLE
K874386 · JCN
R&D Systems, Inc.
Hematology · 65d
Cleared Sep 29, 1987
QBC VENOUS BLOOD CONTROL/MULTIPLE
K873354 · JPK
R&D Systems, Inc.
Hematology · 40d
Cleared Aug 21, 1986
CBC-CAL (TM) PLUS/MULTIPLE
K862858 · KRX
R&D Systems, Inc.
Hematology · 23d
Cleared Feb 13, 1986
CBC-CAL/MULTIPLE
K854823 · KSA
R&D Systems, Inc.
Hematology · 72d
Cleared Nov 26, 1985
PLATELET-TROL II
K854353 · JPK
R&D Systems, Inc.
Hematology · 29d
Cleared Jul 09, 1985
LASER PLATELETCAL/MULTIPLE
K852016 · KRY
R&D Systems, Inc.
Hematology · 61d
Cleared May 13, 1985
CBC-PLT-4/MULTIPLE WHOLE BLOOD HEMATOLOGY CONTROL
K850755 · JPK
R&D Systems, Inc.
Hematology · 77d
Cleared Nov 01, 1984
CBC-PLT-4 WHOLE BLOOD CONTROL/MULTIPLE
K843962 · JPK
R&D Systems, Inc.
Hematology · 21d
Cleared Oct 30, 1984
RETIC-SET
K843619 · KQC
R&D Systems, Inc.
Hematology · 46d
Cleared Oct 01, 1984
HYCEL DILUTOR, VARIOUS MODELS/MULTI
K842747 · GKH
R&D Systems, Inc.
Hematology · 80d
Cleared Aug 17, 1984
HYCEL ROTOR-MIXER AND/OR MULTI
K842746 · KSQ
R&D Systems, Inc.
Hematology · 35d
Cleared May 31, 1984
RETIC-SET
K841848 · KQC
R&D Systems, Inc.
Hematology · 64d
Cleared May 02, 1984
CELLTRAK-B
K834585 · FRZ
R&D Systems, Inc.
Hematology · 125d
Cleared Mar 12, 1984
PLT - 4 PLATELET
K840302 · JPK
R&D Systems, Inc.
Hematology · 48d
Cleared Aug 16, 1983
MASSAGE TABLE AAT-100
K832464 · JFB
R&D Systems, Inc.
Physical Medicine · 21d