The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Beckman Urine Protein Calibrator (ucal).
Device ID | K973928 |
510k Number | K973928 |
Device Name: | BECKMAN URINE PROTEIN CALIBRATOR (UCAL) |
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 |
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 | 1997-12-01 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
15099590222673 | K973928 | 000 |