The following data is part of a premarket notification filed by Baker Instructions Corp. with the FDA for Baker Tdm Theophylline Assay.
| Device ID | K873596 |
| 510k Number | K873596 |
| Device Name: | BAKER TDM THEOPHYLLINE ASSAY |
| Classification | Enzyme Immunoassay, Theophylline |
| Applicant | BAKER INSTRUCTIONS CORP. 3085 SHAWNEE DR. P.O. BOX 2867 Winchester, VA 22601 |
| Contact | R. E Tomalesky |
| Correspondent | R. E Tomalesky BAKER INSTRUCTIONS CORP. 3085 SHAWNEE DR. P.O. BOX 2867 Winchester, VA 22601 |
| Product Code | KLS |
| CFR Regulation Number | 862.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-04 |
| Decision Date | 1987-10-20 |