The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Synchron Cx Systems Uric Acid (uric) Reagent.
| Device ID | K970919 |
| 510k Number | K970919 |
| Device Name: | SYNCHRON CX SYSTEMS URIC ACID (URIC) REAGENT |
| Classification | Acid, Uric, Uricase (colorimetric) |
| 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 | KNK |
| CFR Regulation Number | 862.1775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-12 |
| Decision Date | 1997-05-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590575281 | K970919 | 000 |