Alkphase-B Assay Kit
FDA 510(k) K952768 · Metra Biosystems, Inc.
510(k) numberK952768
Submission
- Device name
- Alkphase-B Assay Kit
- Applicant
- Metra Biosystems, Inc.
Laurel, MD, US - Received
- June 14, 1995
- Decision date
- August 24, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CIN – Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1050
- Specialty
- Clinical Chemistry
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| K981373 | Alkphase-B Assay KitCIN · Traditional | Metra Biosystems, Inc. | 05/27/1998SE |
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More from Hybritech, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K981364 | Pyrilinks-D Assay KitJMM · Traditional | 08/13/1998SE |
| K981373 | Alkphase-B Assay KitCIN · Traditional | 05/27/1998SE |
| K974260 | Pyrilinks-D Assay KitJMM · Traditional | 01/26/1998SE |
| K952320 | Pyrilinks-D Assay KitJMM · Traditional | 12/29/1995SE |
| K952506 | Pyrilinks Assay KitJMM · Traditional | 11/03/1995SE |
| K952026 | Pyrilinks Polyclonal Assay KitJMM · Traditional | 11/03/1995SE |
Questions and answers
When was Alkphase-B Assay Kit cleared by the FDA?
Alkphase-B Assay Kit (K952768) received a 510(k) decision of Substantially Equivalent on August 24, 1995, 71 days after the submission was received.
What is the product code of K952768?
The FDA product code is CIN – Electrophoretic Separation, Alkaline Phosphatase Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1050.