The following data is part of a premarket notification filed by Bartels Immunodiagnostic Supplies, Inc. with the FDA for Direct Immunofluor. Antibody Test Kit.
| Device ID | K810856 |
| 510k Number | K810856 |
| Device Name: | DIRECT IMMUNOFLUOR. ANTIBODY TEST KIT |
| Classification | Antiserum, Cf, Psittacosis (chlamydia Group) |
| Applicant | BARTELS IMMUNODIAGNOSTIC SUPPLIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GPT |
| CFR Regulation Number | 866.3120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-03-30 |
| Decision Date | 1981-05-05 |