Last synced on 23 February 2024 at 11:04 pm

Paper, Obstetric Ph

Page Type
Product Code
Regulation Medical Specialty
Chemistry
Review Panel
Obstetrical and Gynecological
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
862.1550
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 862.1550 Urinary pH (nonquantitative) test system

§ 862.1550 Urinary pH (nonquantitative) test system.

(a) Identification. A urinary pH (nonquantitative) test system is a device intended to estimate the pH of urine. Estimations of pH are used to evaluate the acidity or alkalinity of urine as it relates to numerous renal and metabolic disorders and in the monitoring of patients with certain diets.

(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 2307, Jan. 14, 2000]

Paper, Obstetric Ph

Page Type
Product Code
Regulation Medical Specialty
Chemistry
Review Panel
Obstetrical and Gynecological
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
862.1550
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 862.1550 Urinary pH (nonquantitative) test system

§ 862.1550 Urinary pH (nonquantitative) test system.

(a) Identification. A urinary pH (nonquantitative) test system is a device intended to estimate the pH of urine. Estimations of pH are used to evaluate the acidity or alkalinity of urine as it relates to numerous renal and metabolic disorders and in the monitoring of patients with certain diets.

(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 2307, Jan. 14, 2000]