← Product Code [CEN](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEN) · K822241

# FOLATE/B12 DUO-BEAD RADIOASSAY (K822241)

_Abbott Laboratories · CEN · Oct 26, 1982 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEN/K822241

## Device Facts

- **Applicant:** Abbott Laboratories
- **Product Code:** [CEN](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEN.md)
- **Decision Date:** Oct 26, 1982
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1550
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A urinary pH (nonquantitative) test system is a device intended to estimate the pH of urine. Estimations of pH are used to evaluate the acidity or alkalinity of urine as it relates to numerous renal and metabolic disorders and in the monitoring of patients with certain diets.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEN/K822241](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEN/K822241)

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