The following data is part of a premarket notification filed by Carolina Liquid Chemistries Corp. with the FDA for Carolina Liquid Chemistries Clc 6410 Chemistry Analyzer; Carolina Liquid Chemistries Glucose Reagent, Car.
| Device ID | K133519 |
| 510k Number | K133519 |
| Device Name: | CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMISTRIES GLUCOSE REAGENT, CAR |
| Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
| Applicant | CAROLINA LIQUID CHEMISTRIES CORP. 575 N. PATTERSON AVE. SUITE 430 Winston-salem, NC 27101 |
| Contact | Melissa F Thompson |
| Correspondent | Melissa F Thompson CAROLINA LIQUID CHEMISTRIES CORP. 575 N. PATTERSON AVE. SUITE 430 Winston-salem, NC 27101 |
| Product Code | JJE |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CFR |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | JGS |
| Subsequent Product Code | JIX |
| CFR Regulation Number | 862.2160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-15 |
| Decision Date | 2014-05-16 |
| Summary: | summary |