510(k) K011116
K011116 is an FDA 510(k) premarket notification submitted by Pasco Laboratories, Inc. for the device "PASCO MIC AND MIC/ID PANELS INCLUSION OF ESBL CONFIRMATORY TEST". The FDA issued a decision of Substantially Equivalent on Apr 24, 2001. The device falls under product code LTT (Panels, Test, Susceptibility, Antimicrobial), a Class II device regulated under 21 CFR 866.1640. Pasco Laboratories, Inc. has 65 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 24, 2001
- Date Received
- Feb 21, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Panels, Test, Susceptibility, Antimicrobial
- Device Class
- Class II
- Regulation Number
- 866.1640
- Review Panel
- MI
- Submission Type
- 510(k)