Last synced on 2 December 2022 at 11:04 pm

Radioimmunoassay, Androstenedione

Page Type
Product Code
Regulation Medical Specialty
Chemistry
Review Panel
Chemistry
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
862.1075
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 862.1075 Androstenedione test system

§ 862.1075 Androstenedione test system.

(a) Identification. An androstenedione test system is a device intended to measure androstenedione (a substance secreted by the testes, ovary, and adrenal glands) in serum. Adrostenedione measurements are used in the diagnosis and treatment of females with excessive levels of androgen (male sex hormone) production.

(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 2305, Jan. 14, 2000]

Radioimmunoassay, Androstenedione

Page Type
Product Code
Regulation Medical Specialty
Chemistry
Review Panel
Chemistry
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
862.1075
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 862.1075 Androstenedione test system

§ 862.1075 Androstenedione test system.

(a) Identification. An androstenedione test system is a device intended to measure androstenedione (a substance secreted by the testes, ovary, and adrenal glands) in serum. Adrostenedione measurements are used in the diagnosis and treatment of females with excessive levels of androgen (male sex hormone) production.

(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 2305, Jan. 14, 2000]