ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8K25-25, 8K25-01
FDA 510(k) clearance K063232 · decided 2007-06-19
Clearance details
- K-number
- K063232
- Device name
- ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8K25-25, 8K25-01
- Applicant
- Biokit, S.A.
- Decision
- Substantially Equivalent
- Date received
- 2006-10-25
- Decision date
- 2007-06-19
- Days to decision
- 237 days
- Clearance type
- Traditional
- Product code
- CEW
- Device class
- 2
- Regulation number
- 862.1545
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Barcelona, ES
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ARCHITECT Intact PTH Calibrators consists of 6 bottles (4.0 mL each). Calibrator A contain recall (Z-1671-2014) | Abbott Laboratories | 2014-05-29 |
| ARCHITECT Intact PTH Controls consists of 3 x 1 Bottle (8.0 mL each) of PTH (synthetic pep recall (Z-1672-2014) | Abbott Laboratories | 2014-05-29 |