Paper, Obstetric Ph
Paper, Obstetric pH is a pH-sensitive paper or strip used in obstetric settings to measure the pH of vaginal secretions or amniotic fluid, used to detect ruptured membranes (based on the alkaline pH of amniotic fluid compared to the acidic vaginal environment) or to assess fetal well-being during labor. This device is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is LNW, regulated under 21 CFR 862.1550, within the Clinical Chemistry medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- LNW
- Device Class
- FDA class 1
- Regulation Number
- 862.1550
- Medical Specialty
- Clinical Chemistry
- Review Panel
- OB
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K032161 | PHEM-ALERT | Sep 30, 2003 | Substantially Equivalent | Femtek,Llc. |
| K012230 | PHEM-ALERT | Oct 09, 2001 | Substantially Equivalent | Femtek,Llc. |
| K960648 | PHEM-CHEK | May 13, 1996 | Substantially Equivalent | Femtek, Inc. |
| K850858 | OB-PH - PH TEST PAPER | May 24, 1985 | Substantially Equivalent | Uro Pharmaceuticals, Inc. |
FEI Numbers
This FDA classification entry is associated with 33 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 33 registration numbers. Click on an entry to view related FDA registrations.