SURE CHECK OVULATION PREDICTOR— 510(k) K010244
Substantially EquivalentChembio Diagnostic Systems, Inc.
FDA 510(k) clearance K010244 for SURE CHECK OVULATION PREDICTOR, Substantially Equivalent on 2001-05-02. Applicant: Chembio Diagnostic Systems, Inc.. Device class: 1.
Clearance details
- Applicant
- Chembio Diagnostic Systems, Inc.
- Product code
- Code CEP
- Device class
- Class 1
- Regulation
- 21 CFR 862.1485
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Beverly, MA, US
Recent devices under product code CEP
view allMore clearances from Chembio Diagnostic Systems, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.