510(k) K950182
K950182 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "URINE METHADONE SCREEN FLEX(TM) REAGENT CARTRIDGE". The FDA issued a decision of Substantially Equivalent on March 21, 1995. The device falls under product code DIW (Hemagglutination Inhibition, Methadone), a Class II device regulated under 21 CFR 862.3620. E.I. Dupont DE Nemours & Co., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 21, 1995
- Date Received
- January 17, 1995
- 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