← Product Code [DEB](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEB) · K896483

# QM300 ALPHA2 MACROGLOBULIN ANTIBODY PACK (K896483)

_Kallestad Diag, A Div. of Erbamont, Inc. · DEB · Dec 1, 1989 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEB/K896483

## Device Facts

- **Applicant:** Kallestad Diag, A Div. of Erbamont, Inc.
- **Product Code:** [DEB](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEB.md)
- **Decision Date:** Dec 1, 1989
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5620
- **Device Class:** Class 2
- **Review Panel:** Immunology

## Regulatory Identification

An alpha-2-macroglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the alpha-2-macroglobulin (a serum protein) in plasma. Measurement of alpha-2-macroglobulin may aid in the diagnosis of blood-clotting or clot lysis disorders.

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEB/K896483](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEB/K896483)

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