The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for N Latex Cdt.
| Device ID | K060677 |
| 510k Number | K060677 |
| Device Name: | N LATEX CDT |
| Classification | Test, Carbohydrate Deficient Transferrin |
| Applicant | DADE BEHRING, INC. P.O. BOX 6101 Newark, DE 19714 -6101 |
| Contact | Kathleen Dray-lyons |
| Correspondent | Kathleen Dray-lyons DADE BEHRING, INC. P.O. BOX 6101 Newark, DE 19714 -6101 |
| Product Code | NAO |
| CFR Regulation Number | 862.1360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-14 |
| Decision Date | 2006-08-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768018534 | K060677 | 000 |