Who is the manufacturer of CLINICAL BLOOD GAS MIXTURES?

Oxarc, Inc. submitted the Traditional clearance for CLINICAL BLOOD GAS MIXTURES (K964475).

What is the FDA product code for CLINICAL BLOOD GAS MIXTURES?

JIS. It is classified under 21 CFR 862.1150 as a Class 2 device in the Clinical Chemistry panel.

What is the regulatory pathway for CLINICAL BLOOD GAS MIXTURES?

510(k) clearance (submission type: Traditional).

CLINICAL BLOOD GAS MIXTURES

K964475 · Oxarc, Inc. · JIS · Dec 6, 1996 · Clinical Chemistry

Device Facts

Record ID	K964475
Device Name	CLINICAL BLOOD GAS MIXTURES
Applicant	Oxarc, Inc.
Product Code	JIS · Clinical Chemistry
Decision Date	Dec 6, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1150
Device Class	Class 2

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.