510(k) K760920
K760920 is an FDA 510(k) premarket notification submitted by The Upjohn Co. for the device "CAT-A-KIT". The FDA issued a decision of Substantially Equivalent on November 9, 1976. The device falls under product code CHT (Electrophoretic Method, Catecholamines), a Class I device regulated under 21 CFR 862.1165. The Upjohn Co. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 9, 1976
- Date Received
- October 28, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrophoretic Method, Catecholamines
- Device Class
- Class I
- Regulation Number
- 862.1165
- Review Panel
- CH
- Submission Type