LNW — Paper, Obstetric Ph Class I

FDA Device Classification

FDA product code LNW covers "Paper, Obstetric Ph", a Class I medical device regulated under 21 CFR 862.1550. Submissions are reviewed by the Clinical Chemistry panel. At least 4 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
LNW
Device Class
Class I
Regulation Number
862.1550
Submission Type
Review Panel
OB
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K032161femtekPHEM-ALERTSeptember 30, 2003
K012230femtekPHEM-ALERTOctober 9, 2001
K960648femtekPHEM-CHEKMay 13, 1996
K850858uro pharmaceuticalsOB-PH - PH TEST PAPERMay 24, 1985