The following data is part of a premarket notification filed by Dynatech Laboratories, Inc. with the FDA for Mlx Microtiter Plate Luminometer.
| Device ID | K962265 |
| 510k Number | K962265 |
| Device Name: | MLX MICROTITER PLATE LUMINOMETER |
| Classification | Culture Media, Multiple Biochemical Test |
| Applicant | DYNATECH LABORATORIES, INC. 14340 SULLYFIELD CIRCLE Chantilly, VA 22021 |
| Contact | Larry Pool |
| Correspondent | Larry Pool DYNATECH LABORATORIES, INC. 14340 SULLYFIELD CIRCLE Chantilly, VA 22021 |
| Product Code | JSE |
| CFR Regulation Number | 866.2320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-12 |
| Decision Date | 1996-07-25 |
| Summary: | summary |