510(k) K923684
K923684 is an FDA 510(k) premarket notification submitted by Analytical Products, Inc. for the device "API UNISCEPT MIC/TYPE 2 AND 3 AND MICRO MIC". The FDA issued a decision of Substantially Equivalent on Dec 3, 1992. The device falls under product code JWY (Manual Antimicrobial Susceptibility Test Systems), a Class II device regulated under 21 CFR 866.1640. Analytical Products, Inc. has 56 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 3, 1992
- Date Received
- Jul 23, 1992
- 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)