ACE CLINICAL CHEMISTRY SYSTEM
FDA 510(k) clearance K930104 · decided 1993-08-23
Clearance details
- K-number
- K930104
- Device name
- ACE CLINICAL CHEMISTRY SYSTEM
- Applicant
- Schiapparelli Biosystems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-01-11
- Decision date
- 1993-08-23
- Days to decision
- 224 days
- Clearance type
- Traditional
- Product code
- JIX
- Device class
- 2
- Regulation number
- 862.1150
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Fairfield, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Gemcal Reference Serum (magnesium calibrator). Calibrator, Multianalyte Mixture. Level 1 a recall (Z-0676-06) | Alfa Wassermann, Inc | 2006-03-23 |