The following data is part of a premarket notification filed by Hamilton Co. with the FDA for Discrete Photometric Chemistry Analyzer.
Device ID | K943493 |
510k Number | K943493 |
Device Name: | DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER |
Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
Applicant | HAMILTON CO. 3371 LENORA CHURCH OD Snellville, GA 30278 |
Contact | Timothy Cowart |
Correspondent | Timothy Cowart HAMILTON CO. 3371 LENORA CHURCH OD Snellville, GA 30278 |
Product Code | JJE |
Subsequent Product Code | JJQ |
Subsequent Product Code | JTC |
CFR Regulation Number | 862.2160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-07-19 |
Decision Date | 1995-01-30 |