The following data is part of a premarket notification filed by Beckman-diagnostic Systems Group with the FDA for Beckman Cx Ammonia/alcohol Control.
| Device ID | K934467 |
| 510k Number | K934467 |
| Device Name: | BECKMAN CX AMMONIA/ALCOHOL CONTROL |
| Classification | Alcohol Control Materials |
| Applicant | BECKMAN-DIAGNOSTIC SYSTEMS GROUP 200 SOUTH KRAEMER BLVD. Brea, CA 92621 -6209 |
| Contact | William T Ryan |
| Correspondent | William T Ryan BECKMAN-DIAGNOSTIC SYSTEMS GROUP 200 SOUTH KRAEMER BLVD. Brea, CA 92621 -6209 |
| Product Code | DKC |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-10 |
| Decision Date | 1993-10-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590222734 | K934467 | 000 |
| 15099590222727 | K934467 | 000 |
| 15099590222710 | K934467 | 000 |