The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Immage Immunochemistry System Apolipoprotein A-1 Reagent (apa)/ Immage Immunochemistry System Apolipoprotein B Reagent.
| Device ID | K964010 |
| 510k Number | K964010 |
| Device Name: | IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN A-1 REAGENT (APA)/ IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN B REAGENT |
| Classification | Apolipoproteins |
| Applicant | BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD. W-343 Brea, CA 92822 -8000 |
| Contact | Margie George |
| Correspondent | Margie George BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD. W-343 Brea, CA 92822 -8000 |
| Product Code | MSJ |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-07 |
| Decision Date | 1997-02-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590224035 | K964010 | 000 |
| 15099590223878 | K964010 | 000 |