The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for N Latex Igm.
| Device ID | K032014 |
| 510k Number | K032014 |
| Device Name: | N LATEX IGM |
| Classification | Method, Nephelometric, Immunoglobulins (g, A, M) |
| Applicant | DADE BEHRING, INC. GLASGOW SITE P.O. BOX 6101 Newark, DE 19714 -6101 |
| Contact | Kathleen A Dray-lyons |
| Correspondent | Kathleen A Dray-lyons DADE BEHRING, INC. GLASGOW SITE P.O. BOX 6101 Newark, DE 19714 -6101 |
| Product Code | CFN |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-30 |
| Decision Date | 2003-08-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768007194 | K032014 | 000 |
| 00630414285023 | K032014 | 000 |