SPORVIEW PLUS BI TEST PACK— 510(k) K140620

Name: FDA 510(k) clearance K140620
Creator: U.S. Food and Drug Administration
Published: 2014-08-07

Substantially Equivalent

Crosstex International

FDA 510(k) clearance K140620 for SPORVIEW PLUS BI TEST PACK, Substantially Equivalent on 2014-08-07. Applicant: Crosstex International. Device class: 2.

Clearance details

Applicant: Crosstex International
Product code: Code FRC
Device class: Class 2
Regulation: 21 CFR 880.2800
Advisory panel: General Hospital
Date received: 2014-03-11
Decision date: 2014-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rush, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FRC

view all

K260766 — Celerity 5 HP Biological Indicator (LCB052)2026-04-08
K252680 — Celerity 20 HP Biological Indicator2025-09-24
K251122 — Terragene® Bionova® BT20 Biological Indicator2025-08-04
K251452 — Celerity 5 HP Biological Indicator (LCB052) +3 more2025-06-06
K250044 — Celerity 5 HP Biological Indicator (LCB052) +3 more2025-02-06

More clearances from Crosstex International

view all

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