510(k) K935408
K935408 is an FDA 510(k) premarket notification submitted by Chimera Research & Chemical, Inc. for the device "UA PERFECT". The FDA issued a decision of Substantially Equivalent on June 13, 1994. The device falls under product code KQO (Automated Urinalysis System), a Class I device regulated under 21 CFR 862.2900. Chimera Research & Chemical, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 13, 1994
- Date Received
- November 9, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Automated Urinalysis System
- Device Class
- Class I
- Regulation Number
- 862.2900
- Review Panel
- CH
- Submission Type