EZTEST— 510(k) K963841

Substantially Equivalent

Sgm Biotech, Inc.

FDA 510(k) clearance K963841 for EZTEST, Substantially Equivalent on 1997-02-25. Applicant: Sgm Biotech, Inc.. Device class: 2.

Clearance details

Applicant: Sgm Biotech, Inc.
Product code: Code FRC
Device class: Class 2
Regulation: 21 CFR 880.2800
Advisory panel: General Hospital
Date received: 1996-09-25
Decision date: 1997-02-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bozeman, MT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FRC

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 Sgm Biotech, Inc.

K093794 — SMART-READ EZTEST-STEAM SCBI AND TEST PACK2010-05-14
K091950 — SMART-WELL EZTEST INCUBATOR2010-01-15
K930682 — EZTEST-STEAM1994-04-04

Recalls naming K963841

K-number listed on FDA's recall record

Z-1867-2013 — Mesa EZtest BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy of steam sterilization processes.Class II·Terminated·Mesa Laboratories, Inc., Bozeman Manufacturing Facility·20130604

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K963841.

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