510(k) K830252
K830252 is an FDA 510(k) premarket notification submitted by Granite Diagnostics, Inc. for the device "DIPCHEX DIP-SLIDE CULTURE SYS". The FDA issued a decision of Substantially Equivalent on March 7, 1983. The device falls under product code JXA (Kit, Screening, Urine), a Class I device regulated under 21 CFR 866.2660. Granite Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 7, 1983
- Date Received
- January 25, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Kit, Screening, Urine
- Device Class
- Class I
- Regulation Number
- 866.2660
- Review Panel
- MI
- Submission Type