PROSPORE2 SELF-CONTAINED BIOLOGICAL INDICATOR
FDA 510(k) clearance K994381 · decided 2001-03-30
Clearance details
- K-number
- K994381
- Device name
- PROSPORE2 SELF-CONTAINED BIOLOGICAL INDICATOR
- Applicant
- Raven Biological Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-12-28
- Decision date
- 2001-03-30
- Days to decision
- 458 days
- Clearance type
- Traditional
- Product code
- FRC
- Device class
- 2
- Regulation number
- 880.2800
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Omaha, NE, US
- Third-party review
- No
- Expedited review
- Yes
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Self Contained Biological Indicator, product code SCRE-06, lots 643 and 674. recall (Z-0205-06) | Namsa | 2005-11-29 |