510(k) K812194
K812194 is an FDA 510(k) premarket notification submitted by American Scientific Products for the device "IMMUNODIFFUSION BAND INTENSIFYING FLUID". The FDA issued a decision of Substantially Equivalent on August 31, 1981. The device falls under product code JZS (Electrophoresis Instrumentation), a Class I device regulated under 21 CFR 866.4500. American Scientific Products has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 31, 1981
- Date Received
- August 3, 1981
- 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