510(k) K770411
K770411 is an FDA 510(k) premarket notification submitted by Nuclear Medical Laboratories, Inc. for the device "DIGI TROL TM-RX & DIGI TROL TM-TX". The FDA issued a decision of Substantially Equivalent on Mar 16, 1977. The device falls under product code DMP (Digoxin Control Serum, Ria), a Class I device regulated under 21 CFR 862.3280. Nuclear Medical Laboratories, Inc. has 23 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 16, 1977
- Date Received
- Mar 4, 1977
- 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