510(k) K950353
K950353 is an FDA 510(k) premarket notification submitted by Miles, Inc. for the device "TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM". The FDA issued a decision of Substantially Equivalent on April 20, 1995. The device falls under product code JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use), a Class I device regulated under 21 CFR 862.2160. Miles, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 20, 1995
- Date Received
- January 30, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Device Class
- Class I
- Regulation Number
- 862.2160
- Review Panel
- CH
- Submission Type