The following data is part of a premarket notification filed by Electro-nucleonics Laboratories, Inc. with the FDA for Gemstar Ipa Theophylline Test Kit.
| Device ID | K853372 |
| 510k Number | K853372 |
| Device Name: | GEMSTAR IPA THEOPHYLLINE TEST KIT |
| Classification | Enzyme Immunoassay, Theophylline |
| Applicant | ELECTRO-NUCLEONICS LABORATORIES, INC. 7101 RIVERWOOD DR. Columbia, MD 21046 |
| Contact | Eugene H Labrec |
| Correspondent | Eugene H Labrec ELECTRO-NUCLEONICS LABORATORIES, INC. 7101 RIVERWOOD DR. Columbia, MD 21046 |
| Product Code | KLS |
| CFR Regulation Number | 862.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-12 |
| Decision Date | 1985-09-04 |