SYNTRON BIORESEARCH U-TEST PREGNANCY TEST— 510(k) K874248

Substantially Equivalent

Syntron Bioresearch, Inc.

FDA 510(k) clearance K874248 for SYNTRON BIORESEARCH U-TEST PREGNANCY TEST, Substantially Equivalent on 1987-11-04. Applicant: Syntron Bioresearch, Inc.. Device class: 2.

Clearance details

Applicant
Syntron Bioresearch, Inc.
Product code
Code LCX
Device class
Class 2
Regulation
21 CFR 862.1155
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Diego, CA, US
Download summary PDFView on FDA.gov ↗

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