510(k) K822487
K822487 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "MINITEK GRAM-POSITIVE BROTH & SET AND". The FDA issued a decision of Substantially Equivalent on September 21, 1982. The device falls under product code JSC (Culture Media, General Nutrient Broth), a Class I device regulated under 21 CFR 866.2350. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 21, 1982
- Date Received
- August 17, 1982
- 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