The following data is part of a premarket notification filed by Hamilton Co. with the FDA for Microlab 4000, Microlab 4200.
Device ID | K961896 |
510k Number | K961896 |
Device Name: | MICROLAB 4000, MICROLAB 4200 |
Classification | Station, Pipetting And Diluting, For Clinical Use |
Applicant | HAMILTON CO. 4960 ENERGY WAY Reno, NV 89502 -0012 |
Contact | Wayne Mcauliffe |
Correspondent | Wayne Mcauliffe HAMILTON CO. 4960 ENERGY WAY Reno, NV 89502 -0012 |
Product Code | JQW |
CFR Regulation Number | 862.2750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-05-16 |
Decision Date | 1996-08-16 |