The following data is part of a premarket notification filed by Beckman Coulter Ireland Inc with the FDA for Au Bicarbonate Reagent.
| Device ID | K131546 |
| 510k Number | K131546 |
| Device Name: | AU BICARBONATE REAGENT |
| Classification | Enzymatic, Carbon-dioxide |
| Applicant | BECKMAN COULTER IRELAND INC 250 S. KRAEMER BLVD. E1.SE.01 Brea, CA 92821 |
| Contact | David G Davis |
| Correspondent | David G Davis BECKMAN COULTER IRELAND INC 250 S. KRAEMER BLVD. E1.SE.01 Brea, CA 92821 |
| Product Code | KHS |
| CFR Regulation Number | 862.1160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-29 |
| Decision Date | 2013-10-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590060206 | K131546 | 000 |
| 15099590020187 | K131546 | 000 |
| 15099590010348 | K131546 | 000 |