Biocircuits Ios Quantitative HCG Test Cartridges/Biocircuits Ios Immunoassay Controls
FDA 510(k) K963770 · Biocircuits Corp.
510(k) numberK963770
Submission
- Device name
- Biocircuits Ios Quantitative HCG Test Cartridges/Biocircuits Ios Immunoassay Controls
- Applicant
- Biocircuits Corp.
Sunnyvale, CA, US - Received
- September 19, 1996
- Decision date
- December 5, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JJY – Multi-Analyte Controls, All Kinds (Assayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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More from Aalto Scientific, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K981634 | Biocircuits Ios Prostate Specific Antigen (Psa) Test Cartridges, Biocircuits Ios Psa…LTJ · Traditional | 10/13/1998SE |
| K980819 | Biocircuits Ios Free Thyroxine (FT4) Test Cartridges Biocircuits Ios ControlsCEC · Traditional | 04/03/1998SE |
| K961566 | Biocircuits Ios TSH Test Cartridges/Thyroid ControlsJLW · Traditional | 11/18/1996SE |
| K961792 | Biocircuits Ios Serum Pregnancy Test Cartridges/Immunoassay ControlsDHA · Traditional | 08/21/1996SE |
| K952719 | Biocircuits Ios (In-Office System)KHO · Traditional | 11/22/1995SE |
| K953837 | Biocircuits Ios T4 Test CartridgeKLI · Traditional | 11/20/1995SE |
| K952751 | Biocircuits Ios T4/TU Test CartridgesKLI · Traditional | 11/20/1995SE |
Questions and answers
When was Biocircuits Ios Quantitative HCG Test Cartridges/Biocircuits Ios Immunoassay Controls cleared by the FDA?
Biocircuits Ios Quantitative HCG Test Cartridges/Biocircuits Ios Immunoassay Controls (K963770) received a 510(k) decision of Substantially Equivalent on December 5, 1996, 77 days after the submission was received.
What is the product code of K963770?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.