The following data is part of a premarket notification filed by Genetic Systems Corp. with the FDA for Genetic Systems Microplate Strip Washer.
Device ID | K891766 |
510k Number | K891766 |
Device Name: | GENETIC SYSTEMS MICROPLATE STRIP WASHER |
Classification | Device, Microtiter Diluting/dispensing |
Applicant | GENETIC SYSTEMS CORP. 3005 FIRST AVE. Seattle, WA 98121 |
Contact | Monica S Krieger |
Correspondent | Monica S Krieger GENETIC SYSTEMS CORP. 3005 FIRST AVE. Seattle, WA 98121 |
Product Code | JTC |
CFR Regulation Number | 866.2500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-03-24 |
Decision Date | 1989-05-01 |