510(k) K812985
K812985 is an FDA 510(k) premarket notification submitted by Hoffmann-La Roche, Inc. for the device "AGGLUTEX MORPHINE TEST KIT". The FDA issued a decision of Substantially Equivalent on December 31, 1981. The device falls under product code DDF (Prothrombin, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5735. Hoffmann-La Roche, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 31, 1981
- Date Received
- October 26, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prothrombin, Antigen, Antiserum, Control
- Device Class
- Class I
- Regulation Number
- 866.5735
- Review Panel
- HE
- Submission Type