The following data is part of a premarket notification filed by Immuno-products Industries with the FDA for Immuno-prod Ind Fluore Trepone Antibody Absorped.
| Device ID | K853122 |
| 510k Number | K853122 |
| Device Name: | IMMUNO-PROD IND FLUORE TREPONE ANTIBODY ABSORPED |
| Classification | Anti-human Globulin, Fta-abs Test |
| Applicant | IMMUNO-PRODUCTS INDUSTRIES P.O. BOX 286 So. Bound Brook, NJ 08880 |
| Contact | Howard Rubinstein |
| Correspondent | Howard Rubinstein IMMUNO-PRODUCTS INDUSTRIES P.O. BOX 286 So. Bound Brook, NJ 08880 |
| Product Code | GMS |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-25 |
| Decision Date | 1985-09-19 |