510(k) K953393
K953393 is an FDA 510(k) premarket notification submitted by Chimera Research & Chemical, Inc. for the device "TOX PERFECT A TUBE". The FDA issued a decision of Substantially Equivalent on October 6, 1995. The device falls under product code DMP (Digoxin Control Serum, Ria), a Class I device regulated under 21 CFR 862.3280. Chimera Research & Chemical, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 6, 1995
- Date Received
- July 14, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Digoxin Control Serum, Ria
- Device Class
- Class I
- Regulation Number
- 862.3280
- Review Panel
- TX
- Submission Type