Resolve Systems Alkaline Phosphatase Test Kit
FDA 510(k) K934013 · Isolab, Inc.
510(k) numberK934013
Submission
- Device name
- Resolve Systems Alkaline Phosphatase Test Kit
- Applicant
- Isolab, Inc.
Akron, OH, US - Received
- August 18, 1993
- Decision date
- April 26, 1994
- 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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| K942222 | Quik-Sep Quantitive Hemoglobin S ControlsJCM · Traditional | 01/20/1995SE |
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| K923153 | Hemocard, Hemoglobin C AssayMLL · Traditional | 01/27/1994SE |
| K931234 | Hemocard Control Hb-Aa, Ae, Faa, FaeJCM · Traditional | 05/11/1993SE |
Questions and answers
When was Resolve Systems Alkaline Phosphatase Test Kit cleared by the FDA?
Resolve Systems Alkaline Phosphatase Test Kit (K934013) received a 510(k) decision of Substantially Equivalent on April 26, 1994, 251 days after the submission was received.
What is the product code of K934013?
The FDA product code is CIN – Electrophoretic Separation, Alkaline Phosphatase Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1050.