The following data is part of a premarket notification filed by Bartels Immunodiagnostic Supplies, Inc. with the FDA for Cytomegalovirus Direct Fluorescent Antibody Kit.
| Device ID | K860279 |
| 510k Number | K860279 |
| Device Name: | CYTOMEGALOVIRUS DIRECT FLUORESCENT ANTIBODY KIT |
| Classification | Antisera, Conjugated Fluorescent, Cytomegalovirus |
| Applicant | BARTELS IMMUNODIAGNOSTIC SUPPLIES, INC. P.O. BOX 3093 Bellevue, WA 98009 |
| Contact | Howard Taylor |
| Correspondent | Howard Taylor BARTELS IMMUNODIAGNOSTIC SUPPLIES, INC. P.O. BOX 3093 Bellevue, WA 98009 |
| Product Code | LIN |
| CFR Regulation Number | 866.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-14 |
| Decision Date | 1986-05-13 |