BIOSTAR OIA SHIGATOX
FDA 510(k) clearance K061889 · decided 2006-12-12
Clearance details
- K-number
- K061889
- Device name
- BIOSTAR OIA SHIGATOX
- Applicant
- Inverness Medical-Biostar, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-07-03
- Decision date
- 2006-12-12
- Days to decision
- 162 days
- Clearance type
- Traditional
- Product code
- GMZ
- Device class
- 1
- Regulation number
- 866.3255
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Louisville, CO, US
- Third-party review
- No
- Expedited review
- No
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| QUIX RAPID E. COLI O157 STRIP TEST (K972156) | Guardian Scientific, Corp. | 1997-10-16 |
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| EVOTECH Endoscope Cleaner and Reprocessor System 208V, Product Code: 50004 The EVOTECH ECR recall (Z-0965-2017) | Advanced Sterilization Products | 2017-01-09 |