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
2209–2232 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Jul 21, 1986
KOAGULAB* M COAGULATION SYSTEM
K862537 · JPA
Ortho Diagnostic Systems, Inc.
Hematology · 19d
Cleared Jul 10, 1986
V-MARC 88A COMPUTER
K862089 · KQH
V.Marc, A Div. of Pictorial, Inc.
Hematology · 38d
Cleared Jul 10, 1986
FISHER DIAGNOSTICS HEMATALL-C CALIBRATOR
K862318 · JPK
Fisher Scientific Co., LLC
Hematology · 22d
Cleared Jul 02, 1986
ANTI-LEU-12 B CELL REAGENT
K851639 · LJD
Bd Becton Dickinson Vacutainer...
Hematology · 439d
Cleared Jul 01, 1986
LYPHOCHEK GLYCATED HEMOGLOBIN/WHOLE BLOOD/LEV.I&II
K862186 · JPK
Bio-Rad
Hematology · 22d
Cleared Jun 25, 1986
ASSERA-PLATE VWF KIT
K861417 · GGP
American Bioproducts Co.
Hematology · 71d
Cleared Jun 25, 1986
ASSERA-PLATE PROTEIN C KIT
K861475 · GGP
American Bioproducts Co.
Hematology · 64d
Cleared Jun 23, 1986
PTT AUTOMATE TEST KIT
K861190 · GGW
American Bioproducts Co.
Hematology · 84d
Cleared Jun 19, 1986
STACLOT PROTEIN C TEST KIT
K861079 · GGP
American Bioproducts Co.
Hematology · 90d
Cleared Jun 04, 1986
TE-25 COAGURO METER
K854686 · JBP
Future Impex Corp.
Hematology · 196d
Cleared Jun 04, 1986
ERMA HB-METER MODEL 303N
K854687 · KHG
Future Impex Corp.
Hematology · 196d
Cleared May 29, 1986
PREKALLIKREIN DEFICIENT PLASMA, CAT. NO. B 6765
K861048 · GGP
Sigma Chemical Co.
Hematology · 71d
Cleared May 29, 1986
HIGH MOLECULAR WEIGHT KININOGEN(HMWK) DEF PLASMA
K861049 · GGP
Sigma Chemical Co.
Hematology · 71d
Cleared May 23, 1986
BIOTRACK PROTIME CONTROLS (BIOTRACK PROTIME TEST)
K860719 · JPA
Biotrack, Inc.
Hematology · 86d
Cleared May 23, 1986
BIOTRACK MONITOR (BIOTRACK REAGENT CARTRIDGES)
K860720 · JJQ
Biotrack, Inc.
Hematology · 86d
Cleared May 23, 1986
BIOTRACK PROTIME TEST PROTHROMBIN TIME TEST
K860721 · GJS
Biotrack, Inc.
Hematology · 86d
Cleared May 20, 1986
VWF-IX:AG CONTROL PLASMA
K861217 · GGP
American Bioproducts Co.
Hematology · 50d
Cleared May 16, 1986
GLYCOHEMOGLOBIN, IN-VITRO DIAGNOSTIC REAGENT SET
K860572 · LCP
Pointe Scientific, Inc.,
Hematology · 91d
Cleared May 16, 1986
PROTEIN C CONTROL PLASMA
K861216 · GGP
American Bioproducts Co.
Hematology · 46d
Cleared May 07, 1986
PHA-2 CONVERSION PROGRAM FOR PLATELET ANALYSIS
K860586 · GKL
Diagnostic Technology, Inc.
Hematology · 77d
Cleared May 06, 1986
BIOTEL (TM)/ KIDNEY
K855237 · KHE
American Diagnostic Corp.
Hematology · 126d
Cleared May 01, 1986
SPECTRO VWF
K861159 · GGP
Ramco Laboratories, Inc.
Hematology · 34d
Cleared Apr 18, 1986
SEPRACELL LYMPHOCYTE SEPARATION MEDIUM
K860354 · JCF
Sepratech Corporation C/O Keller and...
Hematology · 78d
Cleared Apr 18, 1986
LYFO-KWIK (TM) COAGULASE PLASMA
K861312 · JTL
Micro-Bio-Logics
Hematology · 10d