The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for N Latex Iga.
| Device ID | K024038 |
| 510k Number | K024038 |
| Device Name: | N LATEX IGA |
| Classification | Iga, Antigen, Antiserum, Control |
| Applicant | DADE BEHRING, INC. P.O. BOX 6101 Newark, DE 19714 |
| Contact | Kathleen A Dray-lyons |
| Correspondent | Kathleen A Dray-lyons DADE BEHRING, INC. P.O. BOX 6101 Newark, DE 19714 |
| Product Code | CZP |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-06 |
| Decision Date | 2003-02-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768007200 | K024038 | 000 |
| 00630414285030 | K024038 | 000 |