510(k) K864493
K864493 is an FDA 510(k) premarket notification submitted by Pasco Laboratories, Inc. for the device "REVISED RESISTANT 5 MIC PANEL". The FDA issued a decision of Substantially Equivalent on Feb 2, 1987. The device falls under product code JWY (Manual Antimicrobial Susceptibility Test Systems), 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
- Feb 2, 1987
- Date Received
- Nov 14, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Manual Antimicrobial Susceptibility Test Systems
- Device Class
- Class II
- Regulation Number
- 866.1640
- Review Panel
- MI
- Submission Type
- 510(k)