The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Stratus Cs Stat Fluorometric Analyzer Bhcg Testpak,test System, Model Cbhcg, Bhcg Calpak,model Cbhcg-c, Bhcg Dilpak, Mod.
| Device ID | K003696 |
| 510k Number | K003696 |
| Device Name: | STRATUS CS STAT FLUOROMETRIC ANALYZER BHCG TESTPAK,TEST SYSTEM, MODEL CBHCG, BHCG CALPAK,MODEL CBHCG-C, BHCG DILPAK, MOD |
| Classification | System, Test, Human Chorionic Gonadotropin |
| Applicant | DADE BEHRING, INC. RT. 896, GLASCOW BLDG. 500 Newark, DE 19714 |
| Contact | Laurence A Potter |
| Correspondent | Laurence A Potter DADE BEHRING, INC. RT. 896, GLASCOW BLDG. 500 Newark, DE 19714 |
| Product Code | DHA |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-30 |
| Decision Date | 2001-01-25 |