510(k) K841661

SYNTHETIC BROTH A.O.A.C. by Oxoid U.S.A., Inc. — Product Code JST

K841661 is an FDA 510(k) premarket notification submitted by Oxoid U.S.A., Inc. for the device "SYNTHETIC BROTH A.O.A.C.". The FDA issued a decision of Substantially Equivalent on May 11, 1984. The device falls under product code JST (Kit, Fastidious Organisms), a Class I device regulated under 21 CFR 866.2660. Oxoid U.S.A., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 1984
Date Received
April 23, 1984
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