The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for N Latex Rf Kit.
| Device ID | K071247 |
| 510k Number | K071247 |
| Device Name: | N LATEX RF KIT |
| Classification | System, Test, Rheumatoid Factor |
| Applicant | DADE BEHRING, INC. GLASGOW SITE P.O. BOX 6101 Newark, DE 19714 -6101 |
| Contact | Helen Lee |
| Correspondent | Helen Lee DADE BEHRING, INC. GLASGOW SITE P.O. BOX 6101 Newark, DE 19714 -6101 |
| Product Code | DHR |
| CFR Regulation Number | 866.5775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-04 |
| Decision Date | 2007-08-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768006890 | K071247 | 000 |
| 00842768006883 | K071247 | 000 |