510(k) K831179
K831179 is an FDA 510(k) premarket notification submitted by General Diagnostics for the device "CEFAZOLIN 30MCG. ANTIMICROBIAL SUSCEP". The FDA issued a decision of Substantially Equivalent on May 9, 1983. The device falls under product code JTN (Susceptibility Test Discs, Antimicrobial), a Class II device regulated under 21 CFR 866.1620. General Diagnostics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 9, 1983
- Date Received
- April 11, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Susceptibility Test Discs, Antimicrobial
- Device Class
- Class II
- Regulation Number
- 866.1620
- Review Panel
- MI
- Submission Type