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 |