510(k) K822487

MINITEK GRAM-POSITIVE BROTH & SET AND by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code JSC

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