510(k) K933123
K933123 is an FDA 510(k) premarket notification submitted by Elias U.S.A., Inc. for the device "SYNELISA TG ANTIBODIES/TPO ANTIBODIES". The FDA issued a decision of Substantially Equivalent on August 23, 1993. The device falls under product code JZS (Electrophoresis Instrumentation), a Class I device regulated under 21 CFR 866.4500. Elias U.S.A., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 23, 1993
- Date Received
- June 28, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrophoresis Instrumentation
- Device Class
- Class I
- Regulation Number
- 866.4500
- Review Panel
- IM
- Submission Type