O.P.T.(TM) OVULATION PREDICTION TEST— 510(k) K870584

Name: FDA 510(k) clearance K870584
Creator: U.S. Food and Drug Administration
Published: 1987-11-25

Substantially Equivalent

Warner-Lambert Co.

FDA 510(k) clearance K870584 for O.P.T.(TM) OVULATION PREDICTION TEST, Substantially Equivalent on 1987-11-25. Applicant: Warner-Lambert Co.. Device class: 1.

Clearance details

Applicant: Warner-Lambert Co.
Product code: Code CEP
Device class: Class 1
Regulation: 21 CFR 862.1485
Advisory panel: Clinical Chemistry
Date received: 1987-02-11
Decision date: 1987-11-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morris Plains, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CEP

view all

K013582 — MAYBE?MOM MINI OVULATION MICROSCOPE2003-01-16
K022829 — INSTANT-VIEW LH OVULATION PREDICTING TEST2002-11-05
K021409 — AT HOME OVULATION TEST, MODEL 90322002-05-24
K013874 — CLEARPLANE EASY OVULATION TEST2002-02-19
K013323 — TCI-31 LIFELONG OVULATION TESTER2001-12-05

More clearances from Warner-Lambert Co.

view all

K024160 — NEOSPORIN SCAR SOLUTION2003-03-17
K893452 — EXTRA STRENGTH EFFERGRIP DENTURE ADHESIVE CREAM1989-06-22
K861510 — MULTILUMEN VIAPIC CENTRAL LINE CATHETER1986-06-09
K852689 — GENERAL DIAGNOSTICS CEFTAZIDIME 30 MCG SUSC DISK1985-08-19
K852967 — GENERAL DIAGNOSTICS' CEFTRIAXONE 30MCG SUSDEP DISK1985-08-19

Data sourced from openFDA. This site is unofficial and independent of the FDA.