510(k) K961046

10B ARGININE BROTH by Remel, L.P. — Product Code JSM

K961046 is an FDA 510(k) premarket notification submitted by Remel, L.P. for the device "10B ARGININE BROTH". The FDA issued a decision of Substantially Equivalent on September 18, 1996. The device falls under product code JSM (Culture Media, Non-Propagating Transport), a Class I device regulated under 21 CFR 866.2390. Remel, L.P. has at least 9 other 510(k) clearances on record.