The following data is part of a premarket notification filed by Bartels Immunodiagnostic Supplies, Inc. with the FDA for Cylomegalovirus Direct Fluorescent Anti.
| Device ID | K820895 |
| 510k Number | K820895 |
| Device Name: | CYLOMEGALOVIRUS DIRECT FLUORESCENT ANTI |
| Classification | Antisera, Conjugated Fluorescent, Cytomegalovirus |
| Applicant | BARTELS IMMUNODIAGNOSTIC SUPPLIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LIN |
| CFR Regulation Number | 866.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-03-30 |
| Decision Date | 1982-05-03 |