510(k) K855233
K855233 is an FDA 510(k) premarket notification submitted by Oxoid U.S.A., Inc. for the device "DIAGNOSTIC REAGENT SET-RPLA". The FDA issued a decision of Substantially Equivalent on November 4, 1986. The device falls under product code GTN (Antisera, Fluorescent, All Types, Staphylococcus Spp.), a Class I device regulated under 21 CFR 866.3700. Oxoid U.S.A., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 4, 1986
- Date Received
- December 31, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antisera, Fluorescent, All Types, Staphylococcus Spp.
- Device Class
- Class I
- Regulation Number
- 866.3700
- Review Panel
- MI
- Submission Type