Biostrip(R) Hcg-One Step Pregnancy Test
FDA 510(k) K950307 · Princeton BioMeditech Corp.
510(k) numberK950307
Submission
- Device name
- Biostrip(R) Hcg-One Step Pregnancy Test
- Applicant
- Princeton BioMeditech Corp.
Princeton, NJ, US - Received
- January 25, 1995
- Decision date
- March 1, 1995
- 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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| 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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| K192790 | Atellica IM Total hCG (ThCG)DHA · Traditional | Siemens Healthcare Diagnostics, Inc. | 10/30/2019SE |
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Questions and answers
When was Biostrip(R) Hcg-One Step Pregnancy Test cleared by the FDA?
Biostrip(R) Hcg-One Step Pregnancy Test (K950307) received a 510(k) decision of Substantially Equivalent on March 1, 1995, 35 days after the submission was received.
What is the product code of K950307?
The FDA product code is DHA – System, Test, Human Chorionic Gonadotropin, a Class II (moderate risk) device regulated under 21 CFR 862.1155.