510(k) K833254
K833254 is an FDA 510(k) premarket notification submitted by Granite Diagnostics, Inc. for the device "STREPTOCOCCUS ID TRIPLATE SYSTEM". The FDA issued a decision of Substantially Equivalent on Oct 28, 1983. The device falls under product code JSI (Culture Media, Selective And Differential), a Class I device regulated under 21 CFR 866.2360. Granite Diagnostics, Inc. has 46 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 28, 1983
- Date Received
- Sep 20, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Culture Media, Selective And Differential
- Device Class
- Class I
- Regulation Number
- 866.2360
- Review Panel
- MI
- Submission Type
- 510(k) Exempt