ISE REAGENTS FOR HITACHI 700 SERIES AND 911 CLINICAL CHEMISTRY SYSTEMS
FDA 510(k) clearance K963734 · decided 1996-10-24
Clearance details
- K-number
- K963734
- Device name
- ISE REAGENTS FOR HITACHI 700 SERIES AND 911 CLINICAL CHEMISTRY SYSTEMS
- Applicant
- Alko Diagnostic Corp.
- Decision
- Substantially Equivalent
- Date received
- 1996-08-29
- Decision date
- 1996-10-24
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- CGZ
- Device class
- 2
- Regulation number
- 862.1170
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Holliston, MA, US
- Third-party review
- No
- Expedited review
- No
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| pHoenix ISE Reagents FOR Olympus AU Chemistry Systems (K020148) | Phoenix Diagnostics, Inc. | 2002-02-04 |
| PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES (K013451) | Phoenix Diagnostics, Inc. | 2001-12-18 |
| DELFIA NEONATAL IRT KIT, MODEL A005-110 (K003664) | Wallac OY | 2001-02-14 |
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Recalls involving this device
No recalls on record reference this clearance.