FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEMATIL 18 (H-18)
K Number: K953643
·
Decision Mar 22, 1996
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
379
Applicant Total
10
Review Days
231
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- HEMATIL 18 (H-18)
- K Number
- K953643
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5220
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Texas Intl. Laboratories, Inc.
- Date Received
- August 4, 1995
- Decision Date
- March 22, 1996
- Product Code
- GKZ
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GKZ | Counter, Differential Cell | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GKZ), ordered by most recent decision date.
XR-Series (XR-10, XR-20) Automated Hematology Analyzers
FDA 510(k)
FDA Class 2
·Hematology
Athelas Home
FDA 510(k)
FDA Class 2
·Hematology
Tru Hematology Test
FDA 510(k)
FDA Class 2
·Hematology
Sysmex XR-Series (XR-10) Automated Hematology Analyzer
FDA 510(k)
FDA Class 2
·Hematology
Sysmex XR-Series (XR-20) Automated Hematology Analyzer
FDA 510(k)
FDA Class 2
·Hematology
Alinity h-series System
FDA 510(k)
FDA Class 2
·Hematology
Other Clearances by Texas Intl. Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K904031 | CHEMA CHOL CHOLESTEROL SYSTEM | Mar 11, 1991 | Substantially Equivalent |
| K900684 | RDW AND MPV INDICES ON HEMAT 12 | Apr 16, 1990 | Substantially Equivalent |
| K900685 | CLOT 2 SEMIAUTOMATIC COAGULATION ANALYZER | Apr 16, 1990 | Substantially Equivalent |
| K884006 | HEMAT 12 | Dec 5, 1988 | Substantially Equivalent |
| K883177 | H 10 OR HEMATIL 10 BLOOD CELL & PLATELET COUNTER | Nov 30, 1988 | Substantially Equivalent |
| K853722 | PLT-4 PLATELET ANALYZER | Jan 17, 1986 | Substantially Equivalent |
| K832886 | FLAME PHOTOMETER T281-T282-T283 | Dec 8, 1983 | Substantially Equivalent |
| K832890 | HEMACOMP 7 OR HEMATIL 7 | Oct 19, 1983 | Substantially Equivalent |
| K831649 | THERMOMIXER S213-PHOTOANALYZER S263 | Aug 24, 1983 | Substantially Equivalent |