Stratus(R) HCG Fluorometric Enzyme Immunoassay
FDA 510(k) K913236 · Baxter Healthcare Corp
510(k) numberK913236
Submission
- Device name
- Stratus(R) HCG Fluorometric Enzyme Immunoassay
- Applicant
- Baxter Healthcare Corp
Miami, FL, US - Received
- July 22, 1991
- Decision date
- August 16, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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(R) HCG Fluorometric Enzyme Immunoassay cleared by the FDA?
Stratus(R) HCG Fluorometric Enzyme Immunoassay (K913236) received a 510(k) decision of Substantially Equivalent on August 16, 1991, 25 days after the submission was received.
What is the product code of K913236?
The FDA product code is DHA – System, Test, Human Chorionic Gonadotropin, a Class II (moderate risk) device regulated under 21 CFR 862.1155.