The following data is part of a premarket notification filed by Dynatech Laboratories, Inc. with the FDA for Microplate Luminometer Ml 1000 (no. 012-101-000).
| Device ID | K871415 |
| 510k Number | K871415 |
| Device Name: | MICROPLATE LUMINOMETER ML 1000 (NO. 012-101-000) |
| Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Applicant | DYNATECH LABORATORIES, INC. 14340 SULLYFIELD CIRCLE Chantilly, VA 22021 |
| Contact | Barry S Lazar |
| Correspondent | Barry S Lazar DYNATECH LABORATORIES, INC. 14340 SULLYFIELD CIRCLE Chantilly, VA 22021 |
| Product Code | JJQ |
| CFR Regulation Number | 862.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-08 |
| Decision Date | 1987-04-22 |