510(k) K923349
K923349 is an FDA 510(k) premarket notification submitted by Polysciences, Inc. for the device "FUNGI FLUOR KIT". The FDA issued a decision of Substantially Equivalent on October 20, 1992. The device falls under product code LYF (Pneumocystis Carinii), a Class II device regulated under 21 CFR 866.3780. Polysciences, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 20, 1992
- Date Received
- July 8, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pneumocystis Carinii
- Device Class
- Class II
- Regulation Number
- 866.3780
- Review Panel
- MI
- Submission Type