STATUS FIRST STREP A
FDA 510(k) clearance K040708 · decided 2004-11-22
Clearance details
- K-number
- K040708
- Device name
- STATUS FIRST STREP A
- Applicant
- Princeton BioMeditech Corp.
- Decision
- Substantially Equivalent
- Date received
- 2004-03-18
- Decision date
- 2004-11-22
- Days to decision
- 249 days
- Clearance type
- Traditional
- Product code
- GTY
- Device class
- 1
- Regulation number
- 866.3740
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Monmouth Junction, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.