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

Filters: Hematology ×
3,297 results
1105–1128 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Mar 13, 1997
SYSMEX SE/RAM-1
K964375 · GKL
Sysmex Corp.
Hematology · 132d
Cleared Mar 12, 1997
PROTIME MICROCOAGULATION SYSTEM
K961835 · GJS
International Technidyne Corp.
Hematology · 303d
Cleared Mar 07, 1997
SPECKTIN-LA TEST SET
K961892 · GFO
Analytical Control Systems, Inc.
Hematology · 295d
Cleared Mar 06, 1997
ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE)
K951632 · GKZ
Ortho Diagnostic Systems, Inc.
Hematology · 699d
Cleared Mar 06, 1997
SPIRIT HEMATOLOGY SYSTEM MODEL LE, CP, & AX
K960072 · GKZ
Biochem Immunosystems (U.S.), Inc.
Hematology · 426d
Cleared Mar 06, 1997
ACTALYKE ACTIVATED CLOTTING TIME TEST SYSTEM/CLOTTING TIME TUBES/WHOLE BLOOD...
K964609 · JBP
Array Medical, Inc.
Hematology · 108d
Cleared Mar 06, 1997
COULTER AC.T SERIES ANALYZER
K964988 · GKZ
Coulter Corp.
Hematology · 83d
Cleared Feb 20, 1997
HEMATACHEK
K964452 · GLK
Richmond Diagnostics, Inc.
Hematology · 106d
Cleared Feb 20, 1997
LYPHOCHEK COAGULATION CONTROL
K964963 · GGN
Bio-Rad
Hematology · 71d
Cleared Feb 18, 1997
STRATEC LIA II ANALYZER
K961142 · JJE
Nichols Institute Diagnostics
Hematology · 334d
Cleared Feb 06, 1997
SYSMEX CA-6000
K964139 · GKP
Dade Intl., Inc.
Hematology · 114d
Cleared Jan 22, 1997
COAG-A-MATE MTX
K962857 · GKP
Organon Teknika Corp.
Hematology · 184d
Cleared Jan 22, 1997
TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS AND CYTO-STAT...
K963263 · GKZ
Coulter Corp.
Hematology · 155d
Cleared Jan 22, 1997
ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERYTHRINE CONJUGATE
K964754 · GKZ
Ortho Diagnostic Systems, Inc.
Hematology · 56d
Cleared Jan 17, 1997
CD3 FITC/CD19 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION
K964856 · GKZ
Caltag Laboratories, Inc.
Hematology · 44d
Cleared Jan 06, 1997
CYTO-STAT TRICHROME CD45-FITC/CD8-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT...
K962305 · GKZ
Coulter Corp.
Hematology · 203d
Cleared Jan 06, 1997
CYTO-STAT TRICHROME CD45-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANITBODY REAGENT...
K962768 · GKZ
Coulter Corp.
Hematology · 203d
Cleared Dec 23, 1996
COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V S
K963111 · GGW
Chromogenix AB
Hematology · 133d
Cleared Dec 23, 1996
CYTO-STAT TRICHROME CD8-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH...
K964618 · GKZ
Coulter Corp.
Hematology · 69d
Cleared Dec 18, 1996
THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS
K962864 · KRZ
Alko Diagnostic Corp.
Hematology · 148d
Cleared Dec 18, 1996
UNIVERSAL REAGENT FACTOR V DEFICIENT PLASMA
K964270 · GGP
Universal Reagents, Inc.
Hematology · 54d
Cleared Dec 18, 1996
UNIVERSAL REAGENT FACTOR X DEFICIENT PLASMA
K964459 · GGP
Universal Reagents, Inc.
Hematology · 41d
Cleared Dec 13, 1996
PROC APC ASSAY, PROC CONTROL PLASMA
K962968 · GGP
Behring Diagnostics, Inc.
Hematology · 136d
Cleared Dec 12, 1996
MULTISET SOFTWARE FOR AUTOMATED FLOW CYTOMETRIC DATA ANALYSIS
K963963 · GKZ
Becton Dickinson Immunocytometry Systems
Hematology · 71d