The following data is part of a premarket notification filed by Dynatech Laboratories, Inc. with the FDA for Microlite Microtiter Plate Luminometer Ml3000.
| Device ID | K923456 |
| 510k Number | K923456 |
| Device Name: | MICROLITE MICROTITER PLATE LUMINOMETER ML3000 |
| Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Applicant | DYNATECH LABORATORIES, INC. 14340 SULLYFIELD CIRCLE Chantilly, VA 22021 |
| Contact | Watren D Gehle |
| Correspondent | Watren D Gehle 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 | 1992-07-14 |
| Decision Date | 1992-10-13 |