The following data is part of a premarket notification filed by Electro-nucleonics Laboratories, Inc. with the FDA for Gemstar System.
| Device ID | K821335 |
| 510k Number | K821335 |
| Device Name: | GEMSTAR SYSTEM |
| Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
| Applicant | ELECTRO-NUCLEONICS LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JJE |
| CFR Regulation Number | 862.2160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-05-05 |
| Decision Date | 1982-07-13 |