The following data is part of a premarket notification filed by Dynatech Laboratories, Inc. with the FDA for Dynatech Mr 250 Manual Microelisa Reader.
| Device ID | K874598 |
| 510k Number | K874598 |
| Device Name: | DYNATECH MR 250 MANUAL MICROELISA READER |
| Classification | Device, Microtiter Diluting/dispensing |
| Applicant | DYNATECH LABORATORIES, INC. 14340 SULLYFIELD CIRCLE Chantilly, VA 22021 |
| Contact | Douglas Pollak |
| Correspondent | Douglas Pollak DYNATECH LABORATORIES, INC. 14340 SULLYFIELD CIRCLE Chantilly, VA 22021 |
| Product Code | JTC |
| CFR Regulation Number | 866.2500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-09 |
| Decision Date | 1987-11-20 |