The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Beckman Calibrator 2 (cal2).
| Device ID | K973932 |
| 510k Number | K973932 |
| Device Name: | BECKMAN CALIBRATOR 2 (CAL2) |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD. W-337 Brea, CA 92821 -6208 |
| Contact | Annette Hellie |
| Correspondent | Annette Hellie BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD. W-337 Brea, CA 92821 -6208 |
| Product Code | JIX |
| Subsequent Product Code | CZP |
| Subsequent Product Code | DCF |
| Subsequent Product Code | DDB |
| Subsequent Product Code | DEB |
| Subsequent Product Code | JBQ |
| Subsequent Product Code | JZG |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-15 |
| Decision Date | 1997-12-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590232634 | K973932 | 000 |