The following data is part of a premarket notification filed by Smith River Biologicals with the FDA for Multiple Biochemical Test.
Device ID | K841204 |
510k Number | K841204 |
Device Name: | MULTIPLE BIOCHEMICAL TEST |
Classification | Culture Media, Multiple Biochemical Test |
Applicant | SMITH RIVER BIOLOGICALS 803 N. Front St. Suite 3 McHenry, IL 60050 |
Product Code | JSE |
CFR Regulation Number | 866.2320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-03-12 |
Decision Date | 1984-04-17 |