The following data is part of a premarket notification filed by Diagnostic Chemicals, Ltd. (usa) with the FDA for Enzymatic Theophylline Reagent, #500-82.
| Device ID | K901510 |
| 510k Number | K901510 |
| Device Name: | ENZYMATIC THEOPHYLLINE REAGENT, #500-82 |
| Classification | Enzyme Immunoassay, Theophylline |
| Applicant | DIAGNOSTIC CHEMICALS, LTD. (USA) 160 CHRISTIAN ST. Oxford, CT 06478 |
| Contact | David Templeton |
| Correspondent | David Templeton DIAGNOSTIC CHEMICALS, LTD. (USA) 160 CHRISTIAN ST. Oxford, CT 06478 |
| Product Code | KLS |
| CFR Regulation Number | 862.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-30 |
| Decision Date | 1990-06-12 |