PROCLINIC ONE-STEP DIPSTICK PREGNANCY TEST

Visual, Pregnancy Hcg, Prescription Use

VANGUARD BIOMEDICAL CORP.

The following data is part of a premarket notification filed by Vanguard Biomedical Corp. with the FDA for Proclinic One-step Dipstick Pregnancy Test.

Pre-market Notification Details

• Device ID: K930014
• 510k Number: K930014
• Device Name: PROCLINIC ONE-STEP DIPSTICK PREGNANCY TEST
• Classification: Visual, Pregnancy Hcg, Prescription Use
• Applicant: VANGUARD BIOMEDICAL CORP. 10225 BARNES CANYON RD., SUITE A-108 San Diego, CA 92121
• Contact: Robert Sargeant
• Correspondent: Robert Sargeant; VANGUARD BIOMEDICAL CORP. 10225 BARNES CANYON RD., SUITE A-108 San Diego, CA 92121
• Product Code: JHI
• CFR Regulation Number: 862.1155 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-01-04
• Decision Date: 1993-03-25

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00722066001202	K930014	000
00722066001042	K930014	000