DBEST ONE-STEP OVULATION TEST
FDA 510(k) clearance K974508 · decided 1998-02-02
Clearance details
- K-number
- K974508
- Device name
- DBEST ONE-STEP OVULATION TEST
- Applicant
- Ameritek, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-12-01
- Decision date
- 1998-02-02
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- CEP
- Device class
- 1
- Regulation number
- 862.1485
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Seattle, WA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.