SERIM DISINTEK REAGENT STRIPS
FDA 510(k) clearance K913943 · decided 1992-03-26
Clearance details
- K-number
- K913943
- Device name
- SERIM DISINTEK REAGENT STRIPS
- Applicant
- Serim Research Corp.
- Decision
- Substantially Equivalent
- Date received
- 1991-09-04
- Decision date
- 1992-03-26
- Days to decision
- 204 days
- Clearance type
- Traditional
- Product code
- MED
- Device class
- 2
- Regulation number
- 880.6885
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Elkhart, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.