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
1201–1224 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Apr 03, 1996
CALIBRATION VERIFICATION ASSESSMENT (CVA)
K960557 · JPK
Streck Laboratories, Inc.
Hematology · 54d
Cleared Mar 29, 1996
MULTI-CENTRIFUGE
K955795 · GKG
Novonx, Inc.
Hematology · 98d
Cleared Mar 28, 1996
MOUSE ANTI-HUMAN CD3, T-CELL, FITC & CD8, T-CELL(SUPPRESSOR/CYTOTOXIC) RPE
K955909 · GKZ
Dako Corp.
Hematology · 90d
Cleared Mar 22, 1996
HEMATIL 18 (H-18)
K953643 · GKZ
Texas Intl. Laboratories, Inc.
Hematology · 231d
Cleared Mar 22, 1996
900UDX URINE PATHOLOGY SYSTEM
K960054 · KQO
Intl. Remote Imaging Systems
Hematology · 78d
Cleared Mar 20, 1996
TRI-COUNT 20
K960471 · JPK
Hematronix, Inc.
Hematology · 48d
Cleared Mar 19, 1996
TRI-COURT 20-T
K960005 · JPK
Hematronix, Inc.
Hematology · 77d
Cleared Mar 18, 1996
TAS PTONE
K955843 · GJS
Cardiovascular Diagnostic Services
Hematology · 83d
Cleared Mar 13, 1996
AMAX CS-190 COAGULATION ANALYZER SYSTEM
K955720 · JPA
Sigma Diagnostics, Inc.
Hematology · 86d
Cleared Mar 12, 1996
YELLOW IRIS URINALYSIS WORKSTATION W/IRISCOPE BODY FLUID ANALYSIS CAPABILITY
K954006 · GKL
Intl. Remote Imaging Systems
Hematology · 200d
Cleared Mar 12, 1996
KC 1A COAGULATION ANALYZER/SET
K955724 · JPA
Sigma Diagnostics, Inc.
Hematology · 85d
Cleared Mar 11, 1996
PORCINE FACTOR VIII
K952321 · GGN
Helena Laboratories
Hematology · 298d
Cleared Mar 11, 1996
SERIES 9100 PLUS AUTOMATED DIFFERENTIAL HEMATOLOGY ANALYZERS
K953598 · GKZ
Serono Diagnostics, Inc.
Hematology · 223d
Cleared Mar 11, 1996
PROTHROMBIN TIME TEST CARD
K954625 · GJS
Cardiovascular Diagnostics, Inc.
Hematology · 166d
Cleared Mar 11, 1996
KC 4A MICRO COAGULATION ANALYZER SET/SYSTEM
K955735 · JPA
Sigma Diagnostics, Inc.
Hematology · 84d
Cleared Mar 01, 1996
PRIMUS VARIANT SYSTEM PVS99
K955283 · GKA
Primus Corp.
Hematology · 106d
Cleared Mar 01, 1996
RNA MEDICAL HEMAT CONTROL
K955630 · JJR
Bionostics, Inc.
Hematology · 81d
Cleared Feb 29, 1996
AALTO SCIENTIFIC LIQUID CEREBROSPINAL FLUID CONTROLS LEVELS I AND II
K952126 · GGP
Aalto Scientific, Ltd.
Hematology · 297d
Cleared Feb 29, 1996
FLOW-COUNT COULTER FLUOROSPHERES
K954688 · GKZ
Coulter Corp.
Hematology · 141d
Cleared Feb 29, 1996
BIOCLOT PROTEIN S
K955738 · GGP
Medical Diagnostic Technologies, Inc.
Hematology · 76d
Cleared Feb 29, 1996
CBC-CAL PLUS HEMATOLOGY CALIBRATOR
K955925 · KRX
R&D Systems, Inc.
Hematology · 69d
Cleared Feb 20, 1996
TRITEST REAGENT CD3 FITC/CD4 PE/CD45 PERCP
K946055 · GKZ
Becton Dickinson Immunocytometry Systems
Hematology · 449d
Cleared Feb 20, 1996
TRITEST REAGENT CD3 FITC/CD19 PE/CD45 PERCP
K950342 · GKZ
Becton Dickinson Immunocytometry Systems
Hematology · 389d
Cleared Feb 14, 1996
CHROM Z-HEPARIN, CAT. NO 5242
K952667 · KFF
Helena Laboratories
Hematology · 247d