510(k) K842660
K842660 is an FDA 510(k) premarket notification submitted by Amico Lab, Inc. for the device "ANTI-SCHISTOSOMA SPECIES KIT". The FDA issued a decision of Substantially Equivalent on October 30, 1984. The device falls under product code GNH (Antigen, Fluorescent Antibody Test, Schistosoma Mansoni), a Class I device regulated under 21 CFR 866.3600. Amico Lab, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 30, 1984
- Date Received
- July 10, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antigen, Fluorescent Antibody Test, Schistosoma Mansoni
- Device Class
- Class I
- Regulation Number
- 866.3600
- Review Panel
- MI
- Submission Type