510(k) K800215
K800215 is an FDA 510(k) premarket notification submitted by Clinical Convenience Products, Inc. for the device "CULTURIA MACCONKEY/CLED #DM87". The FDA issued a decision of Substantially Equivalent on February 13, 1980. The device falls under product code JXA (Kit, Screening, Urine), a Class I device regulated under 21 CFR 866.2660. Clinical Convenience Products, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 13, 1980
- Date Received
- February 4, 1980
- 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