510(k) K011551
K011551 is an FDA 510(k) premarket notification submitted by Chembio Diagnostic Systems, Inc. for the device "SURE CHECK PREGNANCY TEST". The FDA issued a decision of Substantially Equivalent on August 14, 2001. The device falls under product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter), a Class II device regulated under 21 CFR 862.1155. Chembio Diagnostic Systems, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 14, 2001
- Date Received
- May 18, 2001
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Kit, Test, Pregnancy, Hcg, Over The Counter
- Device Class
- Class II
- Regulation Number
- 862.1155
- Review Panel
- CH
- Submission Type