MODIFICATION TO:RAVEN BACTERIAL SPORE STRIPS
FDA 510(k) clearance K032914 · decided 2004-05-25
Clearance details
- K-number
- K032914
- Device name
- MODIFICATION TO:RAVEN BACTERIAL SPORE STRIPS
- Applicant
- Raven Biological Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-09-22
- Decision date
- 2004-05-25
- Days to decision
- 246 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
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Product Name: SPORETRAQ MAIL recall (Z-2331-2026) | HF Acquisition Co LLC | 2026-06-05 |
| Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS Product Name: SPORETRAQ MAIL recall (Z-2332-2026) | HF Acquisition Co LLC | 2026-06-05 |