The following data is part of a premarket notification filed by Universal Micro Reference Laboratory with the FDA for Microtech Bacterial Controls.
| Device ID | K822954 |
| 510k Number | K822954 |
| Device Name: | MICROTECH BACTERIAL CONTROLS |
| Classification | Kit, Quality Control For Culture Media |
| Applicant | UNIVERSAL MICRO REFERENCE LABORATORY 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JTR |
| CFR Regulation Number | 866.2480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-10-04 |
| Decision Date | 1982-11-16 |