The following data is part of a premarket notification filed by Bartels Immunodiagnostic Supplies, Inc. with the FDA for A549 (human Lung Carcinoma) Culture Cells.
| Device ID | K864776 |
| 510k Number | K864776 |
| Device Name: | A549 (HUMAN LUNG CARCINOMA) CULTURE CELLS |
| Classification | Cells, Animal And Human, Cultured |
| 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 | KIR |
| CFR Regulation Number | 864.2280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-08 |
| Decision Date | 1986-12-31 |