510(k) K883494
K883494 is an FDA 510(k) premarket notification submitted by Technicon Instruments Corp. for the device "TECHNICON DPA-1 IMMUNOGLOBULIN G". The FDA issued a decision of Substantially Equivalent on September 7, 1988. The device falls under product code DAH (Gamma Globulin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510. Technicon Instruments Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 7, 1988
- Date Received
- August 16, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gamma Globulin, Antigen, Antiserum, Control
- Device Class
- Class II
- Regulation Number
- 866.5510
- Review Panel
- IM
- Submission Type