Alkaline Phosphatase Marker
FDA 510(k) K792548 · Electrophoresis Corp. of America
510(k) numberK792548
Submission
- Device name
- Alkaline Phosphatase Marker
- Applicant
- Electrophoresis Corp. of America
Mchenry, IL, US - Received
- December 10, 1979
- Decision date
- January 29, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K972666 | Tandem-Mp Ostase Immunoenzymetric AssayCIN · Traditional | Hybritech, Inc. | 09/11/1997SE |
| K964764 | Opus Bone AlpCIN · Traditional | Behring Diagnostics, Inc. | 01/24/1997SE |
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More from Hybritech, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K802396 | General Procedure Agarose FilmJJN · Traditional | 11/26/1980SE |
| K792553 | Agarose Barbital-Edta BufferJJN · Traditional | 01/29/1980SE |
| K792551 | Alkaline Phosphatase ReagentCJH · Traditional | 01/29/1980SE |
| K792547 | Agarose Barbital BufferJJN · Traditional | 01/29/1980SE |
| K792574 | Mopso BufferJCC · Traditional | 01/21/1980SE |
| K792550 | Ponceau S Stain SetKQC · Traditional | 01/16/1980SE |
| K792552 | Amido Black 10B StainHZZ · Traditional | 12/18/1979SE |
| K792549 | Fat Red 7B Stain SetHYD · Traditional | 12/18/1979SE |
| K791657 | LDH Isoenzyme ReagentCFE · Traditional | 09/17/1979SE |
| K791656 | Enzyme Stabilizing Reagent (Esr)CFE · Traditional | 09/17/1979SE |
Questions and answers
When was Alkaline Phosphatase Marker cleared by the FDA?
Alkaline Phosphatase Marker (K792548) received a 510(k) decision of Substantially Equivalent on January 29, 1980, 50 days after the submission was received.
What is the product code of K792548?
The FDA product code is CIN – Electrophoretic Separation, Alkaline Phosphatase Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1050.