Counter, Urine Particle
Product Code: LKM
Hematology In Vitro And Other Medical Laser Products
Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co
Applicable Standards: Laser Products. [1040.10]
Code of Federal Regulations: 864.5200
| Radiation Type | Optical |
| Radition Safety | Product |
| Annual Reports | Yes |
| K210127 | IQ200 System, IChemVELOCITY Automated Urine Chemistry System | Beckman Coulter, Inc. |
| K200811 | Cobas U 701 Microscopy Analyzer | Roche Diagnostics |
| K171883 | Sysmex UF-5000 Fully Automated Urine Particle Analyzer | Sysmex America, Inc. |
| K093861 | IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE | IRIS INTERNATIONAL, INC. |
| K080887 | SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE | SYSMEX AMERICA, INC. |
| K070910 | SYSMEX MODEL UF1000I | SYSMEX AMERICA, INC. |
| K053135 | SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER | SYSMEX AMERICA, INC. |
| K022774 | IQ 200 SYSTEM | INTL. REMOTE IMAGING SYSTEMS |
| K012372 | SYSMEX UF-50 | SYSMEX CORP. |
| K000373 | 939UDX URINE PATHOLOGY SYSTEM | INTL. REMOTE IMAGING SYSTEMS |
| K961054 | SYSMEX UF-100 | SYSMEX CORP. |
| K822823 | HEMATOLOGY COMPUTER-INTERFACE, VISCOUNT | EKO SCANN AB |