510(k) K832256
K832256 is an FDA 510(k) premarket notification submitted by Gelco Diagnostics, Inc. for the device "GOAT ANTI-HUMAN IMMUNOGLOBULINS-". The FDA issued a decision of Substantially Equivalent on October 31, 1983. The device falls under product code DFH (Kappa, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5550. Gelco Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 31, 1983
- Date Received
- June 30, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Kappa, Antigen, Antiserum, Control
- Device Class
- Class II
- Regulation Number
- 866.5550
- Review Panel
- IM
- Submission Type