The following data is part of a premarket notification filed by Beckman Coulter Inc. with the FDA for Ise Reagent, Glucose, Crp Latex, Dxc 700 Au Clinical Chemistry Analyzer.
| Device ID | K161837 |
| 510k Number | K161837 |
| Device Name: | ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer |
| Classification | Electrode, Ion Specific, Sodium |
| Applicant | BECKMAN COULTER INC. 250 S. KRAEMER BLVD. MAILS STOP E1.SE.01 Brea, CA 92821 |
| Contact | Geraldine Fuentespina |
| Correspondent | Geraldine Fuentespina BECKMAN COULTER INC. 250 S. KRAEMER BLVD. MAILS STOP E1.SE.01 Brea, CA 92821 |
| Product Code | JGS |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CFR |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | JJE |
| Subsequent Product Code | NQD |
| CFR Regulation Number | 862.1665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-05 |
| Decision Date | 2016-12-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14987666542545 | K161837 | 000 |
| 14987666542514 | K161837 | 000 |
| 14987666542507 | K161837 | 000 |
| 14987666542491 | K161837 | 000 |