510(k) K832051
K832051 is an FDA 510(k) premarket notification submitted by Austin Biological Laboratories for the device "RIM-HAEMOPHILUS 1 & 2". The FDA issued a decision of Substantially Equivalent on Aug 12, 1983. The device falls under product code JST (Kit, Fastidious Organisms), a Class I device regulated under 21 CFR 866.2660. Austin Biological Laboratories has 44 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 12, 1983
- Date Received
- Jun 24, 1983
- 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