510(k) K831349
K831349 is an FDA 510(k) premarket notification submitted by Granite Diagnostics, Inc. for the device "STREPTOCOCUS ID PLATE". The FDA issued a decision of Substantially Equivalent on May 16, 1983. The device falls under product code JST (Kit, Fastidious Organisms), a Class I device regulated under 21 CFR 866.2660. Granite Diagnostics, Inc. has 46 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 16, 1983
- Date Received
- Apr 25, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Kit, Fastidious Organisms
- Device Class
- Class I
- Regulation Number
- 866.2660
- Review Panel
- MI
- Submission Type
- 510(k) Exempt