The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for N Lp(a) Control Sy.
| Device ID | K013130 |
| 510k Number | K013130 |
| Device Name: | N LP(A) CONTROL SY |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | DADE BEHRING, INC. GLASGOW SITE P.O. BOX 6101 Newark, DE 19714 -6101 |
| Contact | Rebecca S Ayash |
| Correspondent | Rebecca S Ayash DADE BEHRING, INC. GLASGOW SITE P.O. BOX 6101 Newark, DE 19714 -6101 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-19 |
| Decision Date | 2001-10-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414287447 | K013130 | 000 |
| 00842768007248 | K013130 | 000 |