The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Apolipoprotein Calibrator (apo-cal).
Device ID | K953979 |
510k Number | K953979 |
Device Name: | APOLIPOPROTEIN CALIBRATOR (APO-CAL) |
Classification | Calibrator, Multi-analyte Mixture |
Applicant | BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea, CA 92622 -8000 |
Contact | Don W Hart |
Correspondent | Don W Hart BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea, CA 92622 -8000 |
Product Code | JIX |
CFR Regulation Number | 862.1150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-08-23 |
Decision Date | 1995-10-03 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
15099590232023 | K953979 | 000 |