The following data is part of a premarket notification filed by Bioproducts For Science, Inc. with the FDA for Labmaster Beta-2-microglobulin Elisa Test Kit Tm.
| Device ID | K903215 |
| 510k Number | K903215 |
| Device Name: | LABMASTER BETA-2-MICROGLOBULIN ELISA TEST KIT TM |
| Classification | System, Test, Beta-2-microglobulin Immunological |
| Applicant | BIOPRODUCTS FOR SCIENCE, INC. P.O. BOX 29176 Indianapolis, IN 46229 |
| Contact | Dwight R Owens |
| Correspondent | Dwight R Owens BIOPRODUCTS FOR SCIENCE, INC. P.O. BOX 29176 Indianapolis, IN 46229 |
| Product Code | JZG |
| CFR Regulation Number | 866.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-23 |
| Decision Date | 1990-09-25 |