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Acid Phosphatase, Nitrophenylphosphate

Page Type
Product Code
Regulation Medical Specialty
Chemistry
Review Panel
Chemistry
Submission Type
510(K) Exempt
Device Classification
Class 2
Regulation Number
862.1020
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 862.1020 Acid phosphatase (total or prostatic) test system

§ 862.1020 Acid phosphatase (total or prostatic) test system.

(a) Identification. An acid phosphatase (total or prostatic) test system is a device intended to measure the activity of the acid phosphatase enzyme in plasma and serum.

(b) 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.

[52 FR 16122, May 1, 1987, as amended at 84 FR 71796, Dec. 30, 2019]

Acid Phosphatase, Nitrophenylphosphate

Page Type
Product Code
Regulation Medical Specialty
Chemistry
Review Panel
Chemistry
Submission Type
510(K) Exempt
Device Classification
Class 2
Regulation Number
862.1020
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 862.1020 Acid phosphatase (total or prostatic) test system

§ 862.1020 Acid phosphatase (total or prostatic) test system.

(a) Identification. An acid phosphatase (total or prostatic) test system is a device intended to measure the activity of the acid phosphatase enzyme in plasma and serum.

(b) 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.

[52 FR 16122, May 1, 1987, as amended at 84 FR 71796, Dec. 30, 2019]