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Radioimmunoassay, Human Growth Hormone

Page Type
Product Code
Regulation Medical Specialty
Chemistry
Review Panel
Chemistry
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
862.1370
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 862.1370 Human growth hormone test system

§ 862.1370 Human growth hormone test system.

(a) Identification. A human growth hormone test system is a device intended to measure the levels of human growth hormone in plasma. Human growth hormone measurements are used in the diagnosis and treatment of disorders involving the anterior lobe of the pituitary gland.

(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 2306, Jan. 14, 2000]

Radioimmunoassay, Human Growth Hormone

Page Type
Product Code
Regulation Medical Specialty
Chemistry
Review Panel
Chemistry
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
862.1370
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 862.1370 Human growth hormone test system

§ 862.1370 Human growth hormone test system.

(a) Identification. A human growth hormone test system is a device intended to measure the levels of human growth hormone in plasma. Human growth hormone measurements are used in the diagnosis and treatment of disorders involving the anterior lobe of the pituitary gland.

(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 2306, Jan. 14, 2000]