510(k) K801509
K801509 is an FDA 510(k) premarket notification submitted by Technam, Inc. for the device "HI-M-TEST FOR METHADONE TEST #2". The FDA issued a decision of Substantially Equivalent on July 14, 1980. The device falls under product code DIW (Hemagglutination Inhibition, Methadone), a Class II device regulated under 21 CFR 862.3620. Technam, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 14, 1980
- Date Received
- June 30, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hemagglutination Inhibition, Methadone
- Device Class
- Class II
- Regulation Number
- 862.3620
- Review Panel
- TX
- Submission Type