The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Apolipoprotein Control Serum Chd, Model Ouph.
| Device ID | K993310 |
| 510k Number | K993310 |
| Device Name: | APOLIPOPROTEIN CONTROL SERUM CHD, MODEL OUPH |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY; BLDG. 500 MAIL BOX 514 P.o. Box 6101, Newark, DE 19714 -6101 |
| Contact | Donna A Wolf |
| Correspondent | Donna A Wolf DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY; BLDG. 500 MAIL BOX 514 P.o. Box 6101, Newark, DE 19714 -6101 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-04 |
| Decision Date | 1999-11-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768021121 | K993310 | 000 |