FERTILITE OV

Test, Luteinizing Hormone (lh), Over The Counter

PHEROMONE SCIENCES CORP.

The following data is part of a premarket notification filed by Pheromone Sciences Corp. with the FDA for Fertilite Ov.

Pre-market Notification Details

Device IDK020808
510k NumberK020808
Device Name:FERTILITE OV
ClassificationTest, Luteinizing Hormone (lh), Over The Counter
Applicant PHEROMONE SCIENCES CORP. 443 KING ST. EAST 2ND FL Toronto,  CA M5a 1l5
ContactJeffrey T Solate
CorrespondentJeffrey T Solate
PHEROMONE SCIENCES CORP. 443 KING ST. EAST 2ND FL Toronto,  CA M5a 1l5
Product CodeNGE  
CFR Regulation Number862.1485 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-03-12
Decision Date2002-09-23
Summary:summary

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