The following data is part of a premarket notification filed by Bartels Immunodiagnostic Supplies, Inc. with the FDA for American Histo-id Sys Primary Kit Psa Prostate Ant.
| Device ID | K855034 |
| 510k Number | K855034 |
| Device Name: | AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANT |
| Classification | Peroxidase Anti-peroxidase Immunohistochemical Stain |
| Applicant | BARTELS IMMUNODIAGNOSTIC SUPPLIES, INC. P.O. BOX 3093 Bellevue, WA 98009 |
| Contact | Bartels |
| Correspondent | Bartels BARTELS IMMUNODIAGNOSTIC SUPPLIES, INC. P.O. BOX 3093 Bellevue, WA 98009 |
| Product Code | LIJ |
| CFR Regulation Number | 864.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-17 |
| Decision Date | 1986-03-11 |