← Product Code [DBT](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBT) · K872230

# MODEL 366-29 ADAPTAID(TM) ADAPTER SLEEVE (K872230)

_Intermedics, Inc. · DBT · Sep 15, 1987 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94immunological-test-systems/DBT/K872230

## Device Facts

- **Applicant:** Intermedics, Inc.
- **Product Code:** [DBT](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBT.md)
- **Decision Date:** Sep 15, 1987
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5330
- **Device Class:** Class 1
- **Review Panel:** Immunology

## Regulatory Identification

A factor XIII, A, S, immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the factor XIII (a bloodclotting factor), in platelets (A) or serum (S). Measurements of factor XIII, A, S, aid in the diagnosis and treatment of certain bleeding disorders resulting from a deficiency of this factor.

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94immunological-test-systems/DBT/K872230](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94immunological-test-systems/DBT/K872230)

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