The following data is part of a premarket notification filed by Electro-nucleonics Laboratories, Inc. with the FDA for Flexigram Auto Loader System.
| Device ID | K811525 |
| 510k Number | K811525 |
| Device Name: | FLEXIGRAM AUTO LOADER SYSTEM |
| Classification | Analyzer, Chemistry, Centrifugal, For Clinical Use |
| Applicant | ELECTRO-NUCLEONICS LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JJG |
| CFR Regulation Number | 862.2140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-05-29 |
| Decision Date | 1981-06-18 |