← Product Code [DAP](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/DAP) · K002948

# K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT (K002948)

_Kamiya Biomedical Co. · DAP · May 18, 2001 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/DAP/K002948

## Device Facts

- **Applicant:** Kamiya Biomedical Co.
- **Product Code:** [DAP](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/DAP.md)
- **Decision Date:** May 18, 2001
- **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/K002948](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/DAP/K002948)

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