CARESTART-PREGNANCY AND CARESTART PLUS-PREGNANCY— 510(k) K032159

Name: FDA 510(k) clearance K032159
Creator: U.S. Food and Drug Administration
Published: 2003-09-05

Substantially Equivalent

Access Bio Incorporate

FDA 510(k) clearance K032159 for CARESTART-PREGNANCY AND CARESTART PLUS-PREGNANCY, Substantially Equivalent on 2003-09-05. Applicant: Access Bio Incorporate. Device class: 2.

Clearance details

Applicant: Access Bio Incorporate
Product code: Code LCX
Device class: Class 2
Regulation: 21 CFR 862.1155
Advisory panel: Clinical Chemistry
Date received: 2003-07-15
Decision date: 2003-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Brunswick, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LCX

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K243573 — FaStep Early Pregnancy Rapid Test Strip +2 more2025-01-15

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K051925 — CARESTART CARDIAC 3-IN-1 TROPONIN 1/CK-MB/MYOGLOBIN2005-11-29
K031048 — CARESTART HCG COMBO ONE-STEP PREGNANCY TEST AND CARESTART PLUS HCG COMBO ONE-STEP PREGNANCY TEST2003-06-16
K031052 — CARESTART HCG ONE-STEP PREGNANCY TEST2003-06-13

Data sourced from openFDA. This site is unofficial and independent of the FDA.