Hydrasys Agarose Gel Electrophoresis Apparatus/Hydragel 15,30 Protein Kit
FDA 510(k) K960029 · Morax
510(k) numberK960029
Submission
- Device name
- Hydrasys Agarose Gel Electrophoresis Apparatus/Hydragel 15,30 Protein Kit
- Applicant
- Morax
Chelsea, MI, US - Received
- January 2, 1996
- Decision date
- July 17, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CEF – Electrophoretic, Protein Fractionation
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1630
- Specialty
- Clinical Chemistry
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| K913315 | Bio-Rad Total Protein Test KitCEF · Traditional | Bio-Rad | 01/02/1992SE |
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| K981048 | Hydragel 6 CSF KitCFF · Traditional | 10/07/1998SE |
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| K972015 | Hydragel 7,15,30, Chol-Hdl KitLBT · Traditional | 10/27/1997SE |
| K963844 | Hydragel 15 HB A1C KitLCP · Traditional | 04/22/1997SE |
Questions and answers
When was Hydrasys Agarose Gel Electrophoresis Apparatus/Hydragel 15,30 Protein Kit cleared by the FDA?
Hydrasys Agarose Gel Electrophoresis Apparatus/Hydragel 15,30 Protein Kit (K960029) received a 510(k) decision of Substantially Equivalent on July 17, 1996, 197 days after the submission was received.
What is the product code of K960029?
The FDA product code is CEF – Electrophoretic, Protein Fractionation, a Class I (low risk) device regulated under 21 CFR 862.1630.