510(k) K862978
K862978 is an FDA 510(k) premarket notification submitted by Pasco Laboratories, Inc. for the device "RESISTANT 6 MIC PANEL". The FDA issued a decision of Substantially Equivalent on Sep 17, 1986. 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
- Sep 17, 1986
- Date Received
- Aug 7, 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)