510(k) K841204
K841204 is an FDA 510(k) premarket notification submitted by Smith River Biologicals for the device "MULTIPLE BIOCHEMICAL TEST". The FDA issued a decision of Substantially Equivalent on Apr 17, 1984. The device falls under product code JSE (Culture Media, Multiple Biochemical Test), a Class I device regulated under 21 CFR 866.2320. Smith River Biologicals has 11 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 17, 1984
- Date Received
- Mar 12, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Culture Media, Multiple Biochemical Test
- Device Class
- Class I
- Regulation Number
- 866.2320
- Review Panel
- MI
- Submission Type
- 510(k) Exempt