The following data is part of a premarket notification filed by Dynatech Laboratories, Inc. with the FDA for Dynatech Spd 3000, #002-900-0000.
Device ID | K872363 |
510k Number | K872363 |
Device Name: | DYNATECH SPD 3000, #002-900-0000 |
Classification | Station, Pipetting And Diluting, For Clinical Use |
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 | JQW |
CFR Regulation Number | 862.2750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-06-18 |
Decision Date | 1987-07-16 |