510(k) K962423
K962423 is an FDA 510(k) premarket notification submitted by Becton Dickinson Microbiology Systems for the device "BBLCRYSTAL NEISSERIA/HAEMOPHILUS (N/H) SYSTEM". The FDA issued a decision of Substantially Equivalent on Aug 2, 1996. The device falls under product code JST (Kit, Fastidious Organisms), a Class I device regulated under 21 CFR 866.2660. Becton Dickinson Microbiology Systems has 32 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 2, 1996
- Date Received
- Jun 24, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Kit, Fastidious Organisms
- Device Class
- Class I
- Regulation Number
- 866.2660
- Review Panel
- MI
- Submission Type
- 510(k) Exempt