FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Hematology ×
3,294 results
3121–3144 of 3,294
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Jun 28, 1978
ISOTONIC DILUENT
K781008 · GIF
Mallinckrodt Critical Care
Hematology · 9d
Cleared Jun 22, 1978
SYSING AND HEMOGLOBIN REAGENT
K780829 · GKR
Harleco
Hematology · 34d
Cleared Jun 22, 1978
ARANTROL
K780835 · JPK
Aranco Diagnostic Laboratories, Inc.
Hematology · 30d
Cleared Jun 19, 1978
BIOSTATOR GLUCOSE ANALYZER
K780393 · CGA
Miles Laboratories, Inc.
Hematology · 101d
Cleared Jun 14, 1978
CRYOCYTE PACK
K780354 · KSR
Travenol Laboratories, S.A.
Hematology · 103d
Cleared Jun 14, 1978
MLA ELECTRA 750 COAGULATION TIMER
K780810 · JPA
Medical Laboratory Automation...
Hematology · 27d
Cleared Jun 14, 1978
ISOTONIC BUFFERED SALINE
K780830 · GIF
Harleco
Hematology · 26d
Cleared Jun 06, 1978
RECAP
K780665 · KSF
Bca Biological Corp. of America
Hematology · 46d
Cleared Jun 06, 1978
PLATELET CONTROL
K780714 · JPK
Bhp Diagnostix, Inc.
Hematology · 39d
Cleared Jun 02, 1978
VOLUME CONTROL DEVICE VCD-150
K780465 · KZD
Sorensen Research
Hematology · 72d
Cleared Jun 02, 1978
HBF-QUIPLATE METHODOLOGY
K780807 · JBD
Helena Laboratories
Hematology · 29d
Cleared May 19, 1978
MICROCELL COUNTER MODEL CC-108
K780224 · GKL
Toa Medical Electronics USA, Inc.
Hematology · 105d
Cleared May 19, 1978
PLATELETS/CU MM
K780577 · GKZ
Geometric Data, Div. Smithkline Corp.
Hematology · 39d
Cleared May 19, 1978
HEMATOLOGY SLIDE STAINER
K780637 · KPA
A. J. P. Scientific, Inc.
Hematology · 32d
Cleared May 03, 1978
HEMO FEC
K780214 · KHE
Boehringer Mannheim Corp.
Hematology · 84d
Cleared Apr 24, 1978
QUALITY CONTROL SYSTEM, SPECTRA
K780097 · KSF
Bd Becton Dickinson Vacutainer...
Hematology · 95d
Cleared Apr 24, 1978
NORMAL UNASSAYED CONTROL SERA
K780351 · JJY
Macomb Chemical Co.
Hematology · 52d
Cleared Apr 24, 1978
LOW IIONIC STRENGTH SOLUTION
K780413 · KSG
Pfizer, Inc.
Hematology · 40d
Cleared Apr 24, 1978
DISC-PAK ROTATOR
K780544 · GLE
Techhnilab Instruments, Inc.
Hematology · 21d
Cleared Apr 24, 1978
SPECT RIM (LISS)
K780556 · KSG
Bd Becton Dickinson Vacutainer...
Hematology · 19d
Cleared Apr 18, 1978
COVERSLIPPER
K780261 · KIM
Shandon, Inc.
Hematology · 61d
Cleared Apr 18, 1978
ATROXIN
K780355 · JCO
Sigma Chemical Co.
Hematology · 46d
Cleared Apr 18, 1978
SINGLE VIAL LACTATE
K780563 · CFJ
Boehringer Mannheim Corp.
Hematology · 11d
Cleared Mar 30, 1978
PLATELET ROTATOR
K780189 · KSQ
Travenol Laboratories, S.A.
Hematology · 52d