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

2041–2064 of 3,297

Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology

Cleared May 06, 1988

NATELSON TUBES, HEPARIN AND PLAIN

Helps Products, Inc.

Hematology · 46d

Cleared May 06, 1988

CARAWAY TUBES, HEPARIN AND PLAIN

Helps Products, Inc.

Hematology · 43d

Cleared May 06, 1988

CLP ABNORMAL COAGULATION CONTROL

Creative Laboratory Products, Inc.

Hematology · 25d

Cleared May 02, 1988

MINOS AUTOMATIC CELL COUNTER

Hematology · 76d

Cleared May 02, 1988

TECH-CAL(TM)/MULTIPLE

R&D Systems, Inc.

Hematology · 45d

Cleared May 02, 1988

VERIFY(R) REFERENCE PLASMA

Organon Teknika Corp.

Hematology · 33d

Cleared Apr 27, 1988

ENZYGNOST(R) TAT REAGENTS

Behring Diagnostics, Inc.

Hematology · 65d

Cleared Apr 27, 1988

LX-100 SLIDE STAINER

Innovative Medical Systems, Inc.

Hematology · 63d

Cleared Apr 21, 1988

FOR THE DETER. OF HEMOGLOBIN IN PLASMA #527

Sigma Diagnostics, Inc.

Hematology · 107d

Cleared Apr 21, 1988

Helena Laboratories

Hematology · 64d

Cleared Apr 21, 1988

CELL-DYN RAPID-LYSE AND HEMOGLOBLIN

Abbott Diagnostics

Hematology · 36d

Cleared Apr 07, 1988

AUTOLYZER 801 SYSTEM (AUTOMATED CELL COUNTER)

Contraves Medical Instruments, Inc.

Hematology · 98d

Cleared Apr 04, 1988

COULTER VCS LEUKOCYTE DIFFERENTIAL COUNTER

Coulter Electronics, Inc.

Hematology · 55d

Cleared Apr 01, 1988

WESCOR STAIN CONCENTRATE FOR MODEL 7100 AEROSPRAY

Hematology · 52d

Cleared Mar 31, 1988

CELL-DYN ISOTONIC DILUENT

Abbott Diagnostics

Hematology · 15d

Cleared Mar 28, 1988

KINETIC FIBRINOGEN ASSAY

Hematology · 11d

Cleared Mar 23, 1988

CLP PROTHROMBIN TIME TEST

Creative Laboratory Products, Inc.

Hematology · 42d

Cleared Mar 23, 1988

CLP ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST

Creative Laboratory Products, Inc.

Hematology · 9d

Cleared Mar 21, 1988

Medical Specialties, Inc.

Hematology · 38d

Cleared Mar 21, 1988

RETICCOUNT SOFTWARE

Bd Becton Dickinson Vacutainer...

Hematology · 34d

Cleared Mar 18, 1988

CLP 0.02 M CALCIUM CHLORIDE SOLUTION.

Creative Laboratory Products, Inc.

Hematology · 25d

Cleared Mar 18, 1988

CLP 0.1 M SODIUM CITRATE SOLUTION

Creative Laboratory Products, Inc.

Hematology · 25d

Cleared Mar 17, 1988

IONOMETER E-HK AND ACCESSORIES

Smash Ent., Inc.

Hematology · 50d

Cleared Mar 17, 1988

IMMUNOADSORBED FACTOR VII DEFICIENT PLASMA HUMAN

Baxter Healthcare Corp

Hematology · 16d