21 CFR 862.1542
§ 862.1542 Oxalate test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.1542, § 862.1542 Oxalate test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89154
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ys:prov:89154@1- SHA-256
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Full text
(a) Identification. An oxalate test system is a device intended to measure the concentration of oxalate in urine. Measurements of oxalate are used to aid in the diagnosis or treatment of urinary stones or certain other metabolic disorders.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.