Home / 510(k) Clearances / K122362

510(k) K122362

SMART-WELL INCUBATOR by Mesa Laboratories, Inc. — Product Code FRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 2013
Date Received
August 6, 2012
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Indicator, Biological Sterilization Process
Device Class
Class II
Regulation Number
880.2800
Review Panel
HO
Submission Type

Other clearances by Mesa Laboratories, Inc.

  • K201765 — SmartHDM-510 System (September 2, 2020)
  • K191496 — TDS Standard Solution (August 5, 2019)
  • K150657 — Phoenix XL Dialysate Meter (September 21, 2015)
  • K140589 — STERRAD CYCLESURE 24 PLUS BIOLOGICAL INDICATOR (December 3, 2014)
  • K130100 — COMINED STANDARD SOLUTION (April 18, 2013)
  • K112018 — SMART READ EZTEST STEAM (January 30, 2012)
  • K050812 — 90XL INSTRUMENTATION SYSTEM (May 5, 2005)
  • K033330 — CONDUCTIVITY/TDS CALIBRATOR SOLUTION (February 27, 2004)

Other clearances for product code FRC

  • K252680 — Celerity™ 20 HP Biological Indicator (September 24, 2025)
  • K251122 — Terragene® Bionova® BT20 Biological Indicator (August 4, 2025)
  • K251452 — Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB05 (June 6, 2025)
  • K250044 — Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB05 (February 6, 2025)
  • K250061 — Celerity Incubator (February 6, 2025)
  • K243501 — 3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M™ (January 28, 2025)
  • K242453 — Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (December 12, 2024)
  • K242538 — 3M™ Attest™ Super Rapid Readout Biological Indicator 1493; 3M™ Attest™ Super Rap (November 25, 2024)
  • K241959 — 3M™ Attest™ Super Rapid Steam Clear Challenge Pack (1492PCD); 3M™ Attest™ Auto-r (October 18, 2024)
  • K231383 — Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Biono (September 18, 2024)