510(k) K821864

THIOGLYCOLLATE MED. W/VITAMIN K-1 by Granite Diagnostics, Inc. — Product Code JSC

K821864 is an FDA 510(k) premarket notification submitted by Granite Diagnostics, Inc. for the device "THIOGLYCOLLATE MED. W/VITAMIN K-1". The FDA issued a decision of Substantially Equivalent on July 13, 1982. The device falls under product code JSC (Culture Media, General Nutrient Broth), a Class I device regulated under 21 CFR 866.2350. Granite Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 1982
Date Received
June 24, 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