The following data is part of a premarket notification filed by Beckman-diagnostic Systems Group with the FDA for Beckman Direct Bilirubin Reagent.
| Device ID | K934068 |
| 510k Number | K934068 |
| Device Name: | BECKMAN DIRECT BILIRUBIN REAGENT |
| Classification | Diazo Colorimetry, Bilirubin |
| 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 | CIG |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-20 |
| Decision Date | 1994-04-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590625603 | K934068 | 000 |
| 15099590575120 | K934068 | 000 |
| 15099590233310 | K934068 | 000 |