BI-O.K. SELF-CONTAINED BIOLOGICAL INDICATOR— 510(k) K991618

Name: FDA 510(k) clearance K991618
Creator: U.S. Food and Drug Administration
Published: 2001-01-24

Substantially Equivalent

Propper Mfg. Co., Inc.

FDA 510(k) clearance K991618 for BI-O.K. SELF-CONTAINED BIOLOGICAL INDICATOR, Substantially Equivalent on 2001-01-24. Applicant: Propper Mfg. Co., Inc.. Device class: 2.

Clearance details

Applicant: Propper Mfg. Co., Inc.
Product code: Code FRC
Device class: Class 2
Regulation: 21 CFR 880.2800
Advisory panel: General Hospital
Date received: 1999-05-11
Decision date: 2001-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Long Island, 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 Propper Mfg. Co., Inc.

view all

K111453 — STEAM DOT BLU PROCESS INDICATOR2012-04-05
K102894 — CLASSIX CHEMICAL STERILIZATION INDICATOR2011-05-25
K082620 — ONCE-A-DAY VERTOS TEST PACK2009-07-08
K031152 — PROPPER VAPOR LINE PCD (STEAM STERILIZATION PROCESS CHALLENGE TEST)2004-08-17
K991276 — PASS/FAIL CHALLENGE PACK1999-07-12

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