The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for N Protein Standard Uy Calibrator.
| Device ID | K003501 |
| 510k Number | K003501 |
| Device Name: | N PROTEIN STANDARD UY CALIBRATOR |
| Classification | Calibrator, Secondary |
| Applicant | DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY; BLDG. 500 MAIL BOX 514 P.o. Box 6101, Newark, DE 19714 -6101 |
| Contact | Rebecca S Ayash |
| Correspondent | Rebecca S Ayash DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY; BLDG. 500 MAIL BOX 514 P.o. Box 6101, Newark, DE 19714 -6101 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-13 |
| Decision Date | 2001-03-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768007835 | K003501 | 000 |