The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Beckman Antistreptolysin O, Modification.
| Device ID | K915053 |
| 510k Number | K915053 |
| Device Name: | BECKMAN ANTISTREPTOLYSIN O, MODIFICATION |
| Classification | Antistreptolysin - Titer/streptolysin O Reagent |
| 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 | GTQ |
| CFR Regulation Number | 866.3720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-31 |
| Decision Date | 1992-03-19 |