The following data is part of a premarket notification filed by Electro-nucleonics Laboratories, Inc. with the FDA for Multi-access Reagent Dispenser.
| Device ID | K873416 |
| 510k Number | K873416 |
| Device Name: | MULTI-ACCESS REAGENT DISPENSER |
| Classification | Station, Pipetting And Diluting, For Clinical Use |
| Applicant | ELECTRO-NUCLEONICS LABORATORIES, INC. 7101 RIVERWOOD DR. Columbia, MD 21046 |
| Contact | Labrec, Ph.d. |
| Correspondent | Labrec, Ph.d. ELECTRO-NUCLEONICS LABORATORIES, INC. 7101 RIVERWOOD DR. Columbia, MD 21046 |
| Product Code | JQW |
| CFR Regulation Number | 862.2750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-25 |
| Decision Date | 1987-10-09 |