The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Beckman Ma Microalbumin Reagent Kit.
| Device ID | K895883 |
| 510k Number | K895883 |
| Device Name: | BECKMAN MA MICROALBUMIN REAGENT KIT |
| Classification | Turbidimetric Method, Protein Or Albumin (urinary, Non-quant.) |
| Applicant | BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea, CA 92622 -8000 |
| Contact | William T Ryan |
| Correspondent | William T Ryan BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea, CA 92622 -8000 |
| Product Code | JIQ |
| CFR Regulation Number | 862.1645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-05 |
| Decision Date | 1989-12-27 |