The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for N Latex Stfr Reagent.
| Device ID | K991157 |
| 510k Number | K991157 |
| Device Name: | N LATEX STFR REAGENT |
| Classification | Transferrin, Antigen, Antiserum, Control |
| Applicant | DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY; BLDG. 500 MAIL BOX 514 P.o. Box 6101, Newark, DE 19714 -6101 |
| Contact | Carolyn K George |
| Correspondent | Carolyn K George DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY; BLDG. 500 MAIL BOX 514 P.o. Box 6101, Newark, DE 19714 -6101 |
| Product Code | DDG |
| CFR Regulation Number | 866.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-07 |
| Decision Date | 1999-08-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768008061 | K991157 | 000 |
| 00842768008054 | K991157 | 000 |