TBD* ONE-STEP OVULATION PREDICTOR TEST

Radioimmunoassay, Luteinizing Hormone

ARMKEL, LLC.

The following data is part of a premarket notification filed by Armkel, Llc. with the FDA for Tbd* One-step Ovulation Predictor Test.

Pre-market Notification Details

Device IDK973310
510k NumberK973310
Device Name:TBD* ONE-STEP OVULATION PREDICTOR TEST
ClassificationRadioimmunoassay, Luteinizing Hormone
Applicant ARMKEL, LLC. HALF ACRE RD. P.O. BOX 1001 Cranbury,  NJ  08512
ContactTheresa Sines
CorrespondentTheresa Sines
ARMKEL, LLC. HALF ACRE RD. P.O. BOX 1001 Cranbury,  NJ  08512
Product CodeCEP  
CFR Regulation Number862.1485 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-09-03
Decision Date1997-10-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00022600900542 K973310 000
00022600408000 K973310 000
00022600407089 K973310 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.