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
1945–1968 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Feb 03, 1989
COULTER CLONE T1 MONOCLONAL ANTIBODY
K883753 · GKZ
Coulter Immunology
Hematology · 154d
Cleared Feb 03, 1989
COULTER CLONE B4 MONOCLONAL ANTIBODY
K884020 · GKZ
Coulter Immunology
Hematology · 134d
Cleared Feb 03, 1989
ELECTRA 900C AUTOMATIC COAGULATION TIMER
K884863 · GKP
Medical Laboratory Automation...
Hematology · 74d
Cleared Feb 03, 1989
KOAGULAB* 32-S COAGULATION SYSTEM
K885035 · GKP
Ortho Diagnostic Systems, Inc.
Hematology · 60d
Cleared Feb 02, 1989
DADE PROTEIN C CHROMOGENIC ASSAY
K884881 · GGP
Baxter Healthcare Corp
Hematology · 72d
Cleared Feb 02, 1989
DADE(R) PROTOTROL SYNTHETIC SUBSTRATE ASSAY CONTRO
K884901 · GGN
Baxter Healthcare Corp
Hematology · 71d
Cleared Jan 30, 1989
COAGULATION CONTROL PLASMA (NORMAL & ABNORMAL)
K884854 · GGN
Precision Biologicals, Inc.
Hematology · 73d
Cleared Jan 30, 1989
THROMBOPLASTIN
K884855 · GJS
Precision Biologicals, Inc.
Hematology · 73d
Cleared Jan 30, 1989
APTT REAGENT
K884856 · GFO
Precision Biologicals, Inc.
Hematology · 73d
Cleared Jan 27, 1989
EASY-TEST PARTIAL THROMBOPLASTIN TIME PTT #16629
K884702 · GFO
Em Diagnostic Systems, Inc.
Hematology · 79d
Cleared Jan 24, 1989
PALL HEPCHEK (TM) HEPARIN ABSORPTION FILTER
K884534 · JPA
Pall Biomedical Products Co.
Hematology · 88d
Cleared Jan 24, 1989
NOVA CELLTRAK 11 AUTO. HEMA. ANALYZER, CALIBRATORS
K884618 · GKL
Nova Biomedical Corp.
Hematology · 81d
Cleared Jan 10, 1989
HEPCON/SYSTEM B-10 HEPARIN ASSAY/SCREEN/CARTRIDGES
K884590 · KFF
Hemotec, Inc.
Hematology · 68d
Cleared Dec 30, 1988
DADE FACTOR VIII CHROMOGENIC ASSAY
K884544 · GGP
Baxter Healthcare Corp
Hematology · 60d
Cleared Dec 30, 1988
DADE FACTOR IX CHROMOGENIC ASSAY
K884551 · GGP
Baxter Healthcare Corp
Hematology · 60d
Cleared Dec 30, 1988
COAG-A-MATE XC/XC PLUS VERSION D.00 SOFTWARE
K885076 · JPA
Organon Teknika Corp.
Hematology · 22d
Cleared Dec 28, 1988
THROMBIN-PREST REAGENT KIT
K884384 · GJA
American Bioproducts Co.
Hematology · 71d
Cleared Dec 28, 1988
FIBRI-PREST/THROMBIN-PREST CONTROLS
K884385 · GJA
American Bioproducts Co.
Hematology · 71d
Cleared Dec 28, 1988
KD ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT
K884485 · GFO
King Diagnostics, Inc.
Hematology · 64d
Cleared Dec 28, 1988
COULTER STKS
K885093 · GKZ
Coulter Electronics, Inc.
Hematology · 19d
Cleared Dec 28, 1988
FACSMATE SAMPLE HANDLING DEVICE
K885132 · GKL
Bd Becton Dickinson Vacutainer...
Hematology · 16d
Cleared Dec 27, 1988
LABILE LYSING REAGENT
K884315 · LCP
Helena Laboratories
Hematology · 75d
Cleared Dec 27, 1988
CYTO-STAT/COULTER CLONE T11-RD1/B1-FITC MONO. ANTI
K884346 · GKZ
Coulter Immunology
Hematology · 74d
Cleared Dec 27, 1988
KVM BLOOD CELL COUNTER
K884471 · GKL
Kvm Instruments, Inc.
Hematology · 63d