HCG Er Method for the Technicon Immuno 1 System In-Vitro Diagnostic Clinical Method
FDA 510(k) K961351 · Bayer Corp.
510(k) numberK961351
Submission
- Device name
- HCG Er Method for the Technicon Immuno 1 System In-Vitro Diagnostic Clinical Method
- Applicant
- Bayer Corp.
Tarrytown, NY, US - Received
- April 5, 1996
- Decision date
- June 3, 1996
- 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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| K221990 | Access Total ßhCG (5th IS)DHA · Traditional | Beckman Coulter, Inc. | 12/27/2022SE |
| K212221 | Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800…DHA · Traditional | Diazyme Laboratories, Inc. | 12/13/2021SE |
| K203227 | Elecsys HCG STATDHA · Traditional | Roche Diagnostics | 08/18/2021SE |
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Questions and answers
When was HCG Er Method for the Technicon Immuno 1 System In-Vitro Diagnostic Clinical Method cleared by the FDA?
HCG Er Method for the Technicon Immuno 1 System In-Vitro Diagnostic Clinical Method (K961351) received a 510(k) decision of Substantially Equivalent on June 3, 1996, 59 days after the submission was received.
What is the product code of K961351?
The FDA product code is DHA – System, Test, Human Chorionic Gonadotropin, a Class II (moderate risk) device regulated under 21 CFR 862.1155.