STERITEC GREEN CARD PACK BOWIE-DICK TEST MODEL BD 126
FDA 510(k) clearance K122945 · decided 2013-04-30
Clearance details
- K-number
- K122945
- Device name
- STERITEC GREEN CARD PACK BOWIE-DICK TEST MODEL BD 126
- Applicant
- Steritec Products Mfg Co, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-09-24
- Decision date
- 2013-04-30
- Days to decision
- 218 days
- Clearance type
- Abbreviated
- Product code
- JOJ
- Device class
- 2
- Regulation number
- 880.2800
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Engelwood, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.