Human Chorionic Gonadotropin Method
FDA 510(k) K970387 · Dade Chemistry Systems, Inc.
510(k) numberK970387
Submission
- Device name
- Human Chorionic Gonadotropin Method
- Applicant
- Dade Chemistry Systems, Inc.
Glasgow, DE, US - Received
- February 3, 1997
- Decision date
- March 10, 1997
- 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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| K973650 | Troponin (Trop) MethodMMI · Traditional | 10/20/1997SE |
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| K973099 | Prostate Specific Antigen ControlJJX · Traditional | 09/29/1997SE |
| K973101 | Prostate Specific Antigen MethodLTJ · Traditional | 09/18/1997SE |
| K971141 | FT4 Method for the Dimension RXL Clinical Chemistry SystemCEC · Traditional | 04/28/1997SE |
| K970393 | Thyroid Stimulating Hormone MethodJLW · Traditional | 03/03/1997SE |
| K970336 | MMB CalibratorJIT · Traditional | 03/03/1997SE |
| K970396 | Human Chorionic Gonadotropin CalibratorJIW · Traditional | 02/20/1997SE |
| K970389 | Thyroid CalibratorJIT · Traditional | 02/18/1997SE |
| K970343 | MMB MethodJHY · Traditional | 02/14/1997SE |
Questions and answers
When was Human Chorionic Gonadotropin Method cleared by the FDA?
Human Chorionic Gonadotropin Method (K970387) received a 510(k) decision of Substantially Equivalent on March 10, 1997, 35 days after the submission was received.
What is the product code of K970387?
The FDA product code is DHA – System, Test, Human Chorionic Gonadotropin, a Class II (moderate risk) device regulated under 21 CFR 862.1155.