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
2113–2136 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Sep 09, 1987
CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG.
K873348 · GGK
Abbott Diagnostics
Hematology · 20d
Cleared Sep 04, 1987
SPECTRO C
K872941 · GGP
Ramco Laboratories, Inc.
Hematology · 39d
Cleared Aug 28, 1987
TECHNICON H*1 JR.(TM) SYSTEM
K873103 · GKL
Technicon Instruments Corp.
Hematology · 21d
Cleared Aug 27, 1987
PROTHROMBIN TIME TEST
K872537 · GJS
Sclavo, Inc.
Hematology · 63d
Cleared Aug 21, 1987
ASSERACHROM PROTEIN S TEST KIT
K872479 · GGP
American Bioproducts Co.
Hematology · 59d
Cleared Aug 06, 1987
DATA-FI DIMERTEST LATEX ASSAY
K872195 · DAP
American Dade
Hematology · 59d
Cleared Aug 06, 1987
CELL-DYN 610 HEMATOLOGY ANALYZER
K872761 · GKZ
Abbott Diagnostics
Hematology · 24d
Cleared Aug 06, 1987
THROMBOREL S
K872844 · GJS
Behring Diagnostics, Inc.
Hematology · 17d
Cleared Jul 31, 1987
THROMBOSCREEN JOSHUA HEMOGLOBIN S SCREENING KIT
K872217 · GHM
Pacific Hemostasis
Hematology · 52d
Cleared Jul 28, 1987
FOCUS-GHB
K871679 · LCP
Awareness Technology, Inc.
Hematology · 90d
Cleared Jul 23, 1987
EASY-TEST HEMOGLOBIN (HGB) ITEM #16685
K872653 · KHG
Em Diagnostic Systems, Inc.
Hematology · 16d
Cleared Jul 16, 1987
MINOS AUTOMATIC CELL COUNTER
K864579 · GKZ
Abx, Inc.
Hematology · 238d
Cleared Jul 09, 1987
CHROM-TROL
K872377 · JPA
Helena Laboratories
Hematology · 20d
Cleared Jul 06, 1987
MICROMAT MODEL 415 - BICHROMATIC FILTER PHOTOMETER
K871388 · LCP
Bio-Rad
Hematology · 90d
Cleared Jul 06, 1987
DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET
K872360 · GHH
American Dade
Hematology · 18d
Cleared Jul 02, 1987
COULTER COUNTER MODEL S-PLUS STKR
K871837 · GKZ
Coulter Electronics, Inc.
Hematology · 51d
Cleared Jun 24, 1987
SYSMEX M-2000 18-PARAMETER, FULLY AUTO HEMA ANALY.
K871600 · GKZ
Toa Medical Electronics USA, Inc.
Hematology · 61d
Cleared Jun 10, 1987
Q.I.C. BLEEDING TIME DEVICE
K871318 · JCA
Helena Laboratories
Hematology · 68d
Cleared Jun 01, 1987
PDA699/PDA700 PROTAMINE DOSE ASSAY FOR HEP. NEUTRA
K870831 · JPA
International Technidyne Corp.
Hematology · 90d
Cleared May 21, 1987
STACHROM PROTEIN C TEST KIT
K871039 · GGP
American Bioproducts Co.
Hematology · 65d
Cleared May 20, 1987
S-CAL HEMATOLOGY CALIBRATOR
K862122 · KRY
Coulter Electronics, Inc.
Hematology · 351d
Cleared May 20, 1987
URINOSCOPY FUNNEL
K871671 · GHO
Portable Medical Laboratories, Inc.
Hematology · 22d
Cleared Apr 28, 1987
GLYCOSCREEN GLYCOSYLATED HEMOGLOBIN ASSAY KIT
K864643 · LCP
Pacific Hemostasis
Hematology · 153d
Cleared Apr 28, 1987
CLEARVIEW CW-10
K870210 · GKR
Clearview Instruments, Inc.
Hematology · 98d