The following data is part of a premarket notification filed by Chromsystems Instruments & Chemicals Gmbh with the FDA for Chromesytems Toxicology Calibrators And Controls.
| Device ID | K080459 |
| 510k Number | K080459 |
| Device Name: | CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLS |
| Classification | Drug Specific Control Materials |
| Applicant | CHROMSYSTEMS INSTRUMENTS & CHEMICALS GMBH 1733 CANTON LANE SUITE 103 Marietta, GA 30062 -2679 |
| Contact | Cathy Cambria |
| Correspondent | Cathy Cambria CHROMSYSTEMS INSTRUMENTS & CHEMICALS GMBH 1733 CANTON LANE SUITE 103 Marietta, GA 30062 -2679 |
| Product Code | LAS |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-20 |
| Decision Date | 2009-11-17 |
| Summary: | summary |