The following data is part of a premarket notification filed by Gds Diagnostics with the FDA for Gds Enzymatic Theophylline Reagent.
| Device ID | K891761 |
| 510k Number | K891761 |
| Device Name: | GDS ENZYMATIC THEOPHYLLINE REAGENT |
| Classification | U.v. Spectrometry, Theophylline |
| Applicant | GDS DIAGNOSTICS 25235 LEER DR. P.O. BOX 473 Elkhart, IN 46515 |
| Contact | De Castro |
| Correspondent | De Castro GDS DIAGNOSTICS 25235 LEER DR. P.O. BOX 473 Elkhart, IN 46515 |
| Product Code | LCY |
| CFR Regulation Number | 862.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-24 |
| Decision Date | 1989-05-16 |