The following data is part of a premarket notification filed by Bartels & Stout, Inc. with the FDA for Test Kit For Detection Of Antinuclear.
| Device ID | K802527 |
| 510k Number | K802527 |
| Device Name: | TEST KIT FOR DETECTION OF ANTINUCLEAR |
| Classification | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control |
| Applicant | BARTELS & STOUT, INC. P.O. BOX 3093 Bellevue , WA 98009 - |
| Contact | Kevin T Mcgourty |
| Correspondent | Kevin T Mcgourty BARTELS & STOUT, INC. P.O. BOX 3093 Bellevue , WA 98009 - |
| Product Code | DHN |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-10-15 |
| Decision Date | 1981-01-05 |