510(k) K792349
K792349 is an FDA 510(k) premarket notification submitted by Pfizer, Inc. for the device "SUSCEPTIBILITY DISK, CINOXACIN 100 MCG.". The FDA issued a decision of Substantially Equivalent on March 12, 1980. The device falls under product code JNT (Chromatographic, Phospholipids), a Class I device regulated under 21 CFR 862.1575. Pfizer, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 12, 1980
- Date Received
- November 19, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Chromatographic, Phospholipids
- Device Class
- Class I
- Regulation Number
- 862.1575
- Review Panel
- CH
- Submission Type