STERITEC STEAM BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR, MODEL BI 103— 510(k) K001444
Substantially EquivalentSteritec Products, Inc.
FDA 510(k) clearance K001444 for STERITEC STEAM BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR, MODEL BI 103, Substantially Equivalent on 2000-05-15. Applicant: Steritec Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Steritec Products, Inc.
- Product code
- Code JOJ
- Device class
- Class 2
- Regulation
- 21 CFR 880.2800
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Castle Rock, CO, US
Recent devices under product code JOJ
view all- K260181 — LF Process Indicator Tape for Steam Sterilization
- K251991 — SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016) +1 more
- K251035 — DISINTEK PA Test Strips
- K251048 — Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118
- K243876 — VERIFY STEAM Integrating Indicator
More clearances from Steritec Products, Inc.
view all- K083650 — EMU-GRAPH 4 EMULATOR, MODEL CI 144
- K080136 — INSTANT READOUT CHEMICAL INTEGRATOR CHALLENGE PACK, MODEL LT- 105
- K052516 — STERITEC CONTAINER CORD - CI 135, STERITEC PROCESS INDICATOR LABELS - CI 140, STERITEC PROCESS INDICATOR DOTS - CI 137
- K040901 — STERITEC EMU-GRAPH, MODEL NO. CI 131/US
- K024293 — BOWIE-DICK MINI PAK, MODEL BD 115
Recalls naming K001444
K-number listed on FDA's recall record- Z-1828-2013 — Medline Med-Checks BI Test packs with Instant Readout Integrator, SteriTec Product Code PL 200, Distributor Product Code MDS200500IR SteriTec Steam Biological Test Packs with Instant Readout Integrator Card: The Steam Biological Test Pack with Instant Readout Integrator is a steam sterilization monitor designed specifically for biological testing of pre-vacuum steam sterilizers operating at 132¿C (270¿F) for 3 minutes or longer. The Instant Readout Integrator Card gives the operator a prediction of the biological test outcome
- Z-1829-2013 — Cardinal BI Stat Biological Test Pack with Instant Readout Integrator, SteriTec Product Code PL 160/A, Distributor Product Code T40311PE SteriTec Steam Biological Test Packs with Instant Readout Integrator Card: The Steam Biological Test Pack with Instant Readout Integrator is a steam sterilization monitor designed specifically for biological testing of pre-vacuum steam sterilizers operating at 132¿C (270¿F) for 3 minutes or longer. The Instant Readout Integrator Card gives the operator a prediction of the biological test outcome.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K001444.
Data sourced from openFDA. This site is unofficial and independent of the FDA.