The following data is part of a premarket notification filed by Bartels Immunodiagnostic Supplies, Inc. with the FDA for Cultrol-antibiotic/antimycotic Solut.
| Device ID | K834115 |
| 510k Number | K834115 |
| Device Name: | CULTROL-ANTIBIOTIC/ANTIMYCOTIC SOLUT |
| Classification | Supplement, Culture Media |
| Applicant | BARTELS IMMUNODIAGNOSTIC SUPPLIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JSK |
| CFR Regulation Number | 866.2450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-29 |
| Decision Date | 1984-03-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391516747325 | K834115 | 000 |
| 05391516747318 | K834115 | 000 |