← Product Code [CDD](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDD) · K771047

# QUANTA-MATE VITAMIN B-12/FOLATE RA (K771047)

_Bio-Rad · CDD · Jun 27, 1977 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-b%E2%80%94clinical-chemistry-test-systems/CDD/K771047

## Device Facts

- **Applicant:** Bio-Rad
- **Product Code:** [CDD](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDD.md)
- **Decision Date:** Jun 27, 1977
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1810
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A vitamin B12 test system is a device intended to measure vitamin B12 in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-b%E2%80%94clinical-chemistry-test-systems/CDD/K771047](https://fda.innolitics.com/submissions/IM/subpart-b%E2%80%94clinical-chemistry-test-systems/CDD/K771047)

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