21 CFR 862.1655
§ 862.1655 Pyruvic acid test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.1655, § 862.1655 Pyruvic acid test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89179
- Permanent ID
ys:prov:89179@1- SHA-256
8dcc74953c2d4d9f1e5cea398506a1e984e2b7320fc67d78cb5124c74c3ca094
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Full text
(a) Identification. A pyruvic acid test system is a device intended to measure pyruvic acid (an intermediate compound in the metabolism of carbohydrate) in plasma. Measurements obtained by this device are used in the evaluation of electrolyte metabolism and in the diagnosis and treatment of acid-base and electrolyte disturbances or anoxia (the reduction of oxygen in body tissues).
(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.