← Product Code [CDD](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDD) · K854945

# MAGIC NO BOIL B12/FOLATE RADIOIMMUNOASSAY (K854945)

_Ciba Corning Diagnostics Corp. · CDD · Feb 11, 1986 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-b%E2%80%94clinical-chemistry-test-systems/CDD/K854945

## Device Facts

- **Applicant:** Ciba Corning Diagnostics Corp.
- **Product Code:** [CDD](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDD.md)
- **Decision Date:** Feb 11, 1986
- **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/HE/subpart-b%E2%80%94clinical-chemistry-test-systems/CDD/K854945](https://fda.innolitics.com/submissions/HE/subpart-b%E2%80%94clinical-chemistry-test-systems/CDD/K854945)

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