ONE-STEP PREGNANCY TEST

Kit, Test, Pregnancy, Hcg, Over The Counter

W.H.P.M., INC.

The following data is part of a premarket notification filed by W.h.p.m., Inc. with the FDA for One-step Pregnancy Test.

Pre-market Notification Details

• Device ID: K041273
• 510k Number: K041273
• Device Name: ONE-STEP PREGNANCY TEST
• Classification: Kit, Test, Pregnancy, Hcg, Over The Counter
• Applicant: W.H.P.M., INC. 163 CABOT ST. Beverly, MA 01915
• Contact: Fran White
• Correspondent: Fran White; W.H.P.M., INC. 163 CABOT ST. Beverly, MA 01915
• Product Code: LCX
• CFR Regulation Number: 862.1155 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-05-12
• Decision Date: 2004-05-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00860002060408	K041273	000