The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Array Systems Rheumatoid Factor (rfmpe) Reagent.
| Device ID | K971602 |
| 510k Number | K971602 |
| Device Name: | ARRAY SYSTEMS RHEUMATOID FACTOR (RFMPE) REAGENT |
| Classification | System, Test, Rheumatoid Factor |
| Applicant | BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea, CA 92622 -8000 |
| Contact | Annette Hellie |
| Correspondent | Annette Hellie BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea, CA 92622 -8000 |
| Product Code | DHR |
| CFR Regulation Number | 866.5775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-01 |
| Decision Date | 1997-06-27 |
| Summary: | summary |