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 |