The following data is part of a premarket notification filed by Bartels Immunodiagnostic Supplies, Inc. with the FDA for Rotavirus Latex Agglutination Assay.
| Device ID | K861172 |
| 510k Number | K861172 |
| Device Name: | ROTAVIRUS LATEX AGGLUTINATION ASSAY |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rotavirus |
| 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 | LIQ |
| CFR Regulation Number | 866.3405 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-28 |
| Decision Date | 1986-07-01 |