ANSWER OVULATION TEST KIT
FDA 510(k) clearance K871241 · decided 1987-10-02
Clearance details
- K-number
- K871241
- Device name
- ANSWER OVULATION TEST KIT
- Applicant
- Armkel, LLC
- Decision
- Substantially Equivalent
- Date received
- 1987-03-27
- Decision date
- 1987-10-02
- Days to decision
- 189 days
- Clearance type
- Traditional
- Product code
- CEP
- Device class
- 1
- Regulation number
- 862.1485
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Cranbury, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.