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52 FR 16122, May 1, 1987, unless otherwise noted.
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Subscribe to: 21 CFR 862.1542
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Nomenclature changes to part 862 appear at 73 FR 35341, June 23, 2008.
(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.
[52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000]