SMART-READ EZTEST-STEAM SCBI AND TEST PACK— 510(k) K093794
Substantially EquivalentSgm Biotech, Inc.
FDA 510(k) clearance K093794 for SMART-READ EZTEST-STEAM SCBI AND TEST PACK, Substantially Equivalent on 2010-05-14. 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
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Bozeman, MT, US
Recent devices under product code FRC
view allMore clearances from Sgm Biotech, Inc.
view allRecalls naming K093794
K-number listed on FDA's recall record- Z-1994-2013 — Getinge Assure Accufast Biological Indicators, Catalog Number 61301606636 (50 Pack) and 61301606637 (100 Pack), STEAM --- Manufactured for: Getinge USA, Inc. 1777 E. Henrietta Rd., Rochester, NY 14623. Getinge Assure AccuFast Biological Indicators (BIs) are designed for biological testing of 121¿C, 132¿C, 134¿C and 135¿C steam sterilization cycles. The AccuFast BI is a self-contained biological indicator containing Geobacillus stearothermophilus inoculated on a paper carrier and placed in a plastic vial with a small glass ampule containing sterile culture medium. After activation, the plastic vial serves as a culture tube. The chemical indicator on the label changes from blue to black when exposed to steam, distinguishing exposed from unexposed units. This indicator does not indicate adequate sterilization.
- Z-1868-2013 — Mesa Smart-Read EZTEST BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy of steam sterilization processes.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K093794.
Data sourced from openFDA. This site is unofficial and independent of the FDA.