SYNTRON QUIKSTRIP/E.Z. STRIP PREGNANCY HOME TEST

Kit, Test, Pregnancy, Hcg, Over The Counter

SYNTRON BIORESEARCH, INC.

The following data is part of a premarket notification filed by Syntron Bioresearch, Inc. with the FDA for Syntron Quikstrip/e.z. Strip Pregnancy Home Test.

Pre-market Notification Details

• Device ID: K921099
• 510k Number: K921099
• Device Name: SYNTRON QUIKSTRIP/E.Z. STRIP PREGNANCY HOME TEST
• Classification: Kit, Test, Pregnancy, Hcg, Over The Counter
• Applicant: SYNTRON BIORESEARCH, INC. 1080 JOSHUA WAY Vista, CA 92083
• Contact: Benedict Zin
• Correspondent: Benedict Zin; SYNTRON BIORESEARCH, INC. 1080 JOSHUA WAY Vista, CA 92083
• Product Code: LCX
• CFR Regulation Number: 862.1155 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-03-09
• Decision Date: 1992-05-29

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10748349000394	K921099	000
10748349000233	K921099	000
10748349000097	K921099	000
10311917211241	K921099	000
10311917211234	K921099	000
10311917211227	K921099	000
10311917211210	K921099	000
10311917211203	K921099	000