The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Quanititate Gbcc Verifier Set.
| Device ID | K944454 |
| 510k Number | K944454 |
| Device Name: | QUANITITATE GBCC VERIFIER SET |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD. BOX 8000 Brea, CA 92821 -6208 |
| Contact | Don W Hart |
| Correspondent | Don W Hart BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD. BOX 8000 Brea, CA 92821 -6208 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-12 |
| Decision Date | 1995-01-17 |