510(k) K881675
K881675 is an FDA 510(k) premarket notification submitted by Dynatech Laboratories, Inc. for the device "IMMULON 4 FLAT BOTTOM PLATES & REMOVAWELL STRIPS". The FDA issued a decision of Substantially Equivalent on April 21, 1988. The device falls under product code JZQ (Plates And Equipment, Radial Immunodiffusion), a Class I device regulated under 21 CFR 866.4800. Dynatech Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 21, 1988
- Date Received
- April 18, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plates And Equipment, Radial Immunodiffusion
- Device Class
- Class I
- Regulation Number
- 866.4800
- Review Panel
- IM
- Submission Type