The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Synchron Systems Enzymatic Co2 (co2e) Reagent, Model A60291.
| Device ID | K091153 |
| 510k Number | K091153 |
| Device Name: | SYNCHRON SYSTEMS ENZYMATIC CO2 (CO2E) REAGENT, MODEL A60291 |
| Classification | Enzymatic, Carbon-dioxide |
| Applicant | BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. M/S W-110 Brea, CA 92822 |
| Contact | Marine Boyajian |
| Correspondent | Marine Boyajian BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. M/S W-110 Brea, CA 92822 |
| Product Code | KHS |
| CFR Regulation Number | 862.1160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-21 |
| Decision Date | 2009-07-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590625726 | K091153 | 000 |