SIGMA'S CALCIUM PROCEDURE NO. 587
FDA 510(k) clearance K871152 · decided 1987-06-12
Clearance details
- K-number
- K871152
- Device name
- SIGMA'S CALCIUM PROCEDURE NO. 587
- Applicant
- Sigma Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-03-23
- Decision date
- 1987-06-12
- Days to decision
- 81 days
- Clearance type
- Traditional
- Product code
- CIC
- Device class
- 2
- Regulation number
- 862.1145
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- St. Louis, MO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Locking Tear-Away Sheath Introducer Product Line. ACCUGUIDE SINGLE LUMEN 4FR PICC P460K 5/ recall (Z-1062-05) | B. Braun Medical, Inc. | 2005-08-03 |