The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for N Latex Cystatin.
| Device ID | K041878 |
| 510k Number | K041878 |
| Device Name: | N LATEX CYSTATIN |
| Classification | Test, Cystatin C |
| 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 | NDY |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-12 |
| Decision Date | 2004-08-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768007934 | K041878 | 000 |