ELECTRODE, ION SPECIFIC
FDA 510(k) clearance K915675 · decided 1992-04-29
Clearance details
- K-number
- K915675
- Device name
- ELECTRODE, ION SPECIFIC
- Applicant
- Alko Diagnostic Corp.
- Decision
- Substantially Equivalent
- Date received
- 1991-12-19
- Decision date
- 1992-04-29
- Days to decision
- 132 days
- Clearance type
- Traditional
- Product code
- JFP
- Device class
- 2
- Regulation number
- 862.1145
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Holliston, MA, US
- Third-party review
- No
- Expedited review
- No
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| AVL OPTI CRITICAL CARE ANALYZER (K984299) | Avl Scientific Corp. | 1998-12-11 |
| AVL 9181 ELECTROLYTE ANALYZER (K972673) | Avl Scientific Corp. | 1997-08-20 |
| EASYLYTE CALCIUM/CHLORIDE ANALYZER (K963694) | Medica Corp. | 1996-11-27 |
| AVL 9180 ELECTROLYTE ANALYZER (K961458) | Avl Scientific Corp. | 1996-06-12 |
| STAT PROFILE ULTRA F,G,H,I,J, AND K ANALYZERS (K960120) | Nova Biomedical Corp. | 1996-03-11 |
| EASY LYTE CALCIUM ANALYZER (K943091) | Medica Corp. | 1995-01-17 |
| AVL 988-4 ELECTROLYTE ANALYZER (K943702) | Avl Scientific Corp. | 1994-09-09 |
| I-STAT IONIZED CALCIUM TEST (K934642) | I-Stat Corp. | 1993-12-17 |
Recalls involving this device
No recalls on record reference this clearance.