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
2137–2160 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Apr 23, 1987
PT HEPARIN ADSORBENT
K870771 · JPA
Probe-Tek, Inc.
Hematology · 56d
Cleared Apr 23, 1987
PROTEIN S CONTROL PLASMA
K870917 · GGP
American Bioproducts Co.
Hematology · 48d
Cleared Apr 20, 1987
PROTHROMBIN TIME TEST
K870596 · GJS
U. S. Diagnostics, Inc.
Hematology · 69d
Cleared Apr 20, 1987
COAGULATION CONTROL, LEVEL I
K870685 · JPA
U. S. Diagnostics, Inc.
Hematology · 60d
Cleared Apr 20, 1987
COAGULATION CONTROL, LEVEL II
K870686 · JPA
U. S. Diagnostics, Inc.
Hematology · 60d
Cleared Apr 20, 1987
COAGULATION CONTROL, LEVEL III
K870687 · JPA
U. S. Diagnostics, Inc.
Hematology · 60d
Cleared Apr 15, 1987
CYANMETHEMOGLOBIN STANDARD
K871283 · KRZ
U. S. Diagnostics, Inc.
Hematology · 15d
Cleared Apr 14, 1987
CHEMPRO 1000(TM)
K870860 · GKF
Arden Medical Systems, Inc.
Hematology · 42d
Cleared Mar 31, 1987
SYSTEM 9000 AUTOMATED CELL COUNTER
K870603 · GKL
Baker Instructions Corp.
Hematology · 48d
Cleared Mar 31, 1987
O.O2 M CALCIUM CHLORIDE SOLUTION
K870688 · JPA
U. S. Diagnostics, Inc.
Hematology · 40d
Cleared Mar 31, 1987
HL-1 SUPPLEMENT
K870876 · KIT
Ventrex Laboratories, Inc.
Hematology · 28d
Cleared Mar 30, 1987
VWF IMMUNOBLOT
K864701 · GGP
Ramco Laboratories, Inc.
Hematology · 118d
Cleared Mar 25, 1987
MSI HEMATOLOGY CONTROL +
K871067 · JPK
Medical Specialties, Inc.
Hematology · 7d
Cleared Mar 23, 1987
WINPETTE
K871076 · JPH
Ulster Scientific, Inc.
Hematology · 5d
Cleared Mar 19, 1987
DR.BRUNO LANGE MINI-HBA1 PHOTOMETER
K865055 · GKR
Diversa Corp.
Hematology · 85d
Cleared Mar 17, 1987
CELL-DYN 1600 MULTIPARAMETER AUTO. HEMA. ANALYZER
K870233 · GKZ
Abbott Diagnostics
Hematology · 55d
Cleared Mar 17, 1987
COAG-A-MATE(R) XC
K870960 · JPA
Organon Teknika Corp.
Hematology · 7d
Cleared Mar 16, 1987
HAEMOGLOBIN REAGENT - CYANMETHAEMOGLOBIN METHOD
K870363 · KHG
Trace Scientific , Ltd.
Hematology · 47d
Cleared Mar 16, 1987
CHART-TYPE MICRO HEMATOCRIT TUBE READER
K870511 · JPI
Norfolk Scientific, Inc.
Hematology · 39d
Cleared Feb 24, 1987
N-D URINE TUBE SYSTEM (N-D TUBE/CAP/PIPETTE)
K864177 · JXA
Cls Co.
Hematology · 123d
Cleared Feb 13, 1987
ASSERA-PLATE PROTEIN S KIT
K870042
American Bioproducts Co.
Hematology · 39d
Cleared Feb 10, 1987
IMMUNOADSORBED FACTOR X DEFICIENT PLASMA (HUMAN)
K870353 · GGP
American Dade
Hematology · 12d
Cleared Feb 10, 1987
IMMUNOADSORBED FACTOR V DEFICIENT PLASMA (HUMAN)
K870354 · GGP
American Dade
Hematology · 12d
Cleared Feb 06, 1987
ELECTRA(R) 700 AUTOMATIC COAGULATION TIMER
K864532 · JPA
Medical Laboratory Automation...
Hematology · 81d