← Product Code [JZX](/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZX) · K930796

# ISE CALIBRATORS FOR CORNING 600 SERIES ANALYZERS (K930796)

_Alko Diagnostic Corp. · JZX · Jan 13, 1994 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZX/K930796

## Device Facts

- **Applicant:** Alko Diagnostic Corp.
- **Product Code:** [JZX](/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZX.md)
- **Decision Date:** Jan 13, 1994
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.4830
- **Device Class:** Class 1
- **Review Panel:** Immunology

## Regulatory Identification

Rocket immunoelectrophoresis equipment for clinical use is a device used to perform a specific test on proteins by using a procedure called rocket immunoelectrophoresis. In this procedure, an electric current causes the protein in solution to migrate through agar gel containing specific antisera. The protein precipitates with the antisera in a rocket-shaped pattern, giving the name to the device. The height of the peak (or the area under the peak) is proportional to the concentration of the protein.

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZX/K930796](https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZX/K930796)

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