510(k) K854483
K854483 is an FDA 510(k) premarket notification submitted by Kallestad Laboratories, Inc. for the device "KALLESTAD QUANTIMETRIC PLUS IGG REAGENT KIT". The FDA issued a decision of Substantially Equivalent on December 11, 1985. The device falls under product code KTO (Reagent, Immunoassay, Igg), a Class I device regulated under 21 CFR 866.5530. Kallestad Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 11, 1985
- Date Received
- November 7, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Reagent, Immunoassay, Igg
- Device Class
- Class I
- Regulation Number
- 866.5530
- Review Panel
- IM
- Submission Type