510(k) K841221
K841221 is an FDA 510(k) premarket notification submitted by Anaerobe Systems for the device "BRAIN HEART INFUSION BROTH". The FDA issued a decision of Substantially Equivalent on Apr 4, 1984. The device falls under product code JSC (Culture Media, General Nutrient Broth), a Class I device regulated under 21 CFR 866.2350. Anaerobe Systems has 51 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 4, 1984
- Date Received
- Mar 22, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Culture Media, General Nutrient Broth
- Device Class
- Class I
- Regulation Number
- 866.2350
- Review Panel
- MI
- Submission Type
- 510(k) Exempt