510(k) K791551
K791551 is an FDA 510(k) premarket notification submitted by Technam, Inc. for the device "HI-M-TEST MORPHINE". The FDA issued a decision of Substantially Equivalent on October 17, 1979. The device falls under product code DLR (Hemagglutination Inhibition, Morphine), a Class II device regulated under 21 CFR 862.3640. Technam, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 17, 1979
- Date Received
- August 14, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hemagglutination Inhibition, Morphine
- Device Class
- Class II
- Regulation Number
- 862.3640
- Review Panel
- TX
- Submission Type