ASSERT TM BIOLOGICAL/CHEMICAL INDICATOR— 510(k) K855101

Name: FDA 510(k) clearance K855101
Creator: U.S. Food and Drug Administration
Published: 1986-07-17

Substantially Equivalent

Surgicot, Inc.

FDA 510(k) clearance K855101 for ASSERT TM BIOLOGICAL/CHEMICAL INDICATOR, Substantially Equivalent on 1986-07-17. Applicant: Surgicot, Inc.. Device class: 2.

Clearance details

Applicant: Surgicot, Inc.
Product code: Code FRC
Device class: Class 2
Regulation: 21 CFR 880.2800
Advisory panel: General Hospital
Date received: 1985-12-23
Decision date: 1986-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Smithtown, 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 Surgicot, Inc.

view all

K962605 — PRO-GUARD DOUBLE-DUTY STERILIZATION WRAP (SINGLE USE)1997-03-11
K931270 — SURGICLEAN ENZYMATIC INSTRUMENT CLEANER1994-04-13
K863122 — ASSERT BIOLOGICAL/CHEMICAL INDICATOR 12 MONTH EXP.1986-12-17
K854631 — ASSERT EO BIOLOGICAL TEST PACK1986-05-27
K854902 — SURGICOT STEAM TEST PACK1986-05-20

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