The following data is part of a premarket notification filed by Dynatech Corp. with the FDA for Dynatech Mr4000 Microplate Reader.
Device ID | K904567 |
510k Number | K904567 |
Device Name: | DYNATECH MR4000 MICROPLATE READER |
Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
Applicant | DYNATECH CORP. 14340 SULLYFIELD CIRCLE Chantilly, VA 22021 |
Contact | John Hope |
Correspondent | John Hope DYNATECH CORP. 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 | 1990-10-09 |
Decision Date | 1991-01-28 |