The following data is part of a premarket notification filed by Smith River Biologicals with the FDA for Single Biochemical Test.
| Device ID | K841212 |
| 510k Number | K841212 |
| Device Name: | SINGLE BIOCHEMICAL TEST |
| Classification | Culture Media, Single Biochemical Test |
| Applicant | SMITH RIVER BIOLOGICALS 803 N. Front St. Suite 3 McHenry, IL 60050 |
| Product Code | JSF |
| 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 | 1984-04-04 |