510(k) K973973
K973973 is an FDA 510(k) premarket notification submitted by Boehringer Mannheim Corp. for the device "ELECSYS CALLCHECK DIGOXIN". The FDA issued a decision of Substantially Equivalent on Nov 4, 1997. The device falls under product code DMP (Digoxin Control Serum, Ria), a Class I device regulated under 21 CFR 862.3280. Boehringer Mannheim Corp. has 339 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 4, 1997
- Date Received
- Oct 20, 1997
- 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
- 510(k) Exempt