510(k) K844380
K844380 is an FDA 510(k) premarket notification submitted by Anaerobe Systems for the device "BILE DIFFERENTIAL DISK". The FDA issued a decision of Substantially Equivalent on Jan 4, 1985. The device falls under product code JTO (Discs, Strips And Reagents, Microorganism Differentiation), a Class I device regulated under 21 CFR 866.2660. Anaerobe Systems has 51 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 4, 1985
- Date Received
- Nov 13, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Discs, Strips And Reagents, Microorganism Differentiation
- Device Class
- Class I
- Regulation Number
- 866.2660
- Review Panel
- MI
- Submission Type
- 510(k) Exempt