Modified Beta Quik Stat Eia Kit
FDA 510(k) K882895 · Pacific Biotech, Inc.
510(k) numberK882895
Submission
- Device name
- Modified Beta Quik Stat Eia Kit
- Applicant
- Pacific Biotech, Inc.
San Diego, CA, US - Received
- July 11, 1988
- Decision date
- October 12, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| K895390 | Cards O.S. (TM) Hcg-UrineJHI · Traditional | 11/13/1989SE |
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| K884616 | Firstday Early Pregnancy Testing Kit IIJHI · Traditional | 01/13/1989SE |
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Questions and answers
When was Modified Beta Quik Stat Eia Kit cleared by the FDA?
Modified Beta Quik Stat Eia Kit (K882895) received a 510(k) decision of Substantially Equivalent on October 12, 1988, 93 days after the submission was received.
What is the product code of K882895?
The FDA product code is DHA – System, Test, Human Chorionic Gonadotropin, a Class II (moderate risk) device regulated under 21 CFR 862.1155.