Stratus CS Stat Fluorometric Analyzer BHCG Testpak,Test System, Model Cbhcg, BHCG Calpak,Model Cbhcg-C, BHCG Dilpak, Mod
FDA 510(k) K003696 · Dade Behring, Inc.
510(k) numberK003696
Submission
- Device name
- Stratus CS Stat Fluorometric Analyzer BHCG Testpak,Test System, Model Cbhcg, BHCG Calpak,Model Cbhcg-C, BHCG Dilpak, Mod
- Applicant
- Dade Behring, Inc.
Newark, DE, US - Received
- November 30, 2000
- Decision date
- January 25, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DHA – System, Test, Human Chorionic Gonadotropin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1155
- Specialty
- Clinical Chemistry
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Questions and answers
When was Stratus CS Stat Fluorometric Analyzer BHCG Testpak,Test System, Model Cbhcg, BHCG Calpak,Model Cbhcg-C, BHCG Dilpak, Mod cleared by the FDA?
Stratus CS Stat Fluorometric Analyzer BHCG Testpak,Test System, Model Cbhcg, BHCG Calpak,Model Cbhcg-C, BHCG Dilpak, Mod (K003696) received a 510(k) decision of Substantially Equivalent on January 25, 2001, 56 days after the submission was received.
What is the product code of K003696?
The FDA product code is DHA – System, Test, Human Chorionic Gonadotropin, a Class II (moderate risk) device regulated under 21 CFR 862.1155.