The following data is part of a premarket notification filed by Packard Instrument Co., Inc. with the FDA for Micromate 196 Model A961960.
Device ID | K901808 |
510k Number | K901808 |
Device Name: | MICROMATE 196 MODEL A961960 |
Classification | Device, Microtiter Diluting/dispensing |
Applicant | PACKARD INSTRUMENT CO., INC. 2200 WARRENVILLE RD. Downers Grove, IL 60515 |
Contact | Dorothy Mrkvicka |
Correspondent | Dorothy Mrkvicka PACKARD INSTRUMENT CO., INC. 2200 WARRENVILLE RD. Downers Grove, IL 60515 |
Product Code | JTC |
CFR Regulation Number | 866.2500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-04-20 |
Decision Date | 1990-06-20 |