← Product Code [DAP](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/DAP) · K890189

# AGEN DIMERTEST EIA (K890189)

_Agen Biomedical , Ltd. · DAP · Mar 3, 1989 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/DAP/K890189

## Device Facts

- **Applicant:** Agen Biomedical , Ltd.
- **Product Code:** [DAP](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/DAP.md)
- **Decision Date:** Mar 3, 1989
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.7320
- **Device Class:** Class 2
- **Review Panel:** Hematology

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/DAP/K890189](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/DAP/K890189)

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