The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Synchron Systems Ammonia (amm) Reagent.
| Device ID | K984402 |
| 510k Number | K984402 |
| Device Name: | SYNCHRON SYSTEMS AMMONIA (AMM) REAGENT |
| Classification | Enzymatic Method, Ammonia |
| Applicant | BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. W-110 Brea, CA 92822 |
| Contact | Lucinda Stockert |
| Correspondent | Lucinda Stockert BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. W-110 Brea, CA 92822 |
| Product Code | JIF |
| CFR Regulation Number | 862.1065 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-09 |
| Decision Date | 1999-01-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590222635 | K984402 | 000 |