The following data is part of a premarket notification filed by Bayer Diagnostics Corp. with the FDA for Acid Phosphatase Assay For The Advia 1650.
Device ID | K023840 |
510k Number | K023840 |
Device Name: | ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650 |
Classification | Acid Phosphatase, Naphthyl Phosphate |
Applicant | BAYER DIAGNOSTICS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
Contact | Andres Holle |
Correspondent | Andres Holle BAYER DIAGNOSTICS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
Product Code | CKB |
Subsequent Product Code | JIX |
Subsequent Product Code | JJY |
CFR Regulation Number | 862.1020 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-11-18 |
Decision Date | 2003-01-07 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05055273200065 | K023840 | 000 |
00630414475677 | K023840 | 000 |