510(k) K884720
K884720 is an FDA 510(k) premarket notification submitted by Remel Co. for the device "GERM TUBE SOLUTION". The FDA issued a decision of Substantially Equivalent on June 2, 1989. The device falls under product code JXC (Kit, Screening, Yeast), a Class I device regulated under 21 CFR 866.2660. Remel Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 2, 1989
- Date Received
- November 10, 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