Chembio Diagnostic Systems, Inc. · Class I · Cleared May 2, 2001
| K-number | K010244 |
| Device name | SURE CHECK OVULATION PREDICTOR |
| Applicant | Chembio Diagnostic Systems, Inc. |
| Product code | CEP |
| Device class | Class I |
| Decision date | May 2, 2001 |
| Decision | Substantially Equivalent |
| Regulation | 862.1485 |
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