510(k) K882371
K882371 is an FDA 510(k) premarket notification submitted by The Cancer Center AT Wadley Institutes for the device "SOC SLIDE CULTURE SYSTEM". The FDA issued a decision of Substantially Equivalent on July 18, 1988. The device falls under product code JXC (Kit, Screening, Yeast), a Class I device regulated under 21 CFR 866.2660.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 18, 1988
- Date Received
- June 8, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Kit, Screening, Yeast
- Device Class
- Class I
- Regulation Number
- 866.2660
- Review Panel
- MI
- Submission Type