The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Cx(tm) Barbiturates(barb) Reagent For Synchron Cx Syst.
| Device ID | K944075 |
| 510k Number | K944075 |
| Device Name: | CX(TM) BARBITURATES(BARB) REAGENT FOR SYNCHRON CX SYST |
| Classification | Enzyme Immunoassay, Barbiturate |
| Applicant | BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea, CA 92622 -8000 |
| Contact | Sheri Hall |
| Correspondent | Sheri Hall BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea, CA 92622 -8000 |
| Product Code | DIS |
| Subsequent Product Code | DKB |
| Subsequent Product Code | DLJ |
| CFR Regulation Number | 862.3150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-05 |
| Decision Date | 1994-12-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590230517 | K944075 | 000 |
| 15099590223007 | K944075 | 000 |