510(k) K964689
K964689 is an FDA 510(k) premarket notification submitted by Accumed Intl., Inc. for the device "TRACCELL 2000 SLIDE MAPPING SYSTEM". The FDA issued a decision of Substantially Equivalent on Aug 18, 1997. The device falls under product code JOY (Device, Automated Cell-Locating), a Class II device regulated under 21 CFR 864.5260. Accumed Intl., Inc. has 11 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 18, 1997
- Date Received
- Nov 22, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Device, Automated Cell-Locating
- Device Class
- Class II
- Regulation Number
- 864.5260
- Review Panel
- HE
- Submission Type
- 510(k)