FDA 510(k)

STERITEC STEAM BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR, MODEL BI 103

K-Number: K001444 · 2000-05-15

Decision Date2000-05-15

Product CodeJOJ

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

STERITEC STEAM BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR, MODEL BI 103 is the device name listed in this FDA 510(k) record. The listed applicant is Steritec Products, Inc.. It received FDA 510(k) clearance on 2000-05-15 under 510(k) number K001444. The device is classified under product code JOJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERITEC STEAM BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR, MODEL BI 103?

STERITEC STEAM BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR, MODEL BI 103 is a medical device that received FDA 510(k) clearance on 2000-05-15. The listed applicant is Steritec Products, Inc.. The 510(k) number is K001444.

When did STERITEC STEAM BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR, MODEL BI 103 receive FDA 510(k) clearance?

STERITEC STEAM BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR, MODEL BI 103 received FDA 510(k) clearance on 2000-05-15, under 510(k) number K001444.

Who is the listed applicant for STERITEC STEAM BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR, MODEL BI 103?

The FDA 510(k) record lists Steritec Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERITEC STEAM BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR, MODEL BI 103?

The FDA product code for STERITEC STEAM BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR, MODEL BI 103 is JOJ.

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Other records listing Steritec Products, Inc. as applicant

K083650EMU-GRAPH 4 EMULATOR, MODEL CI 144 K080136INSTANT READOUT CHEMICAL INTEGRATOR CHALLENGE PACK, MODEL LT- 105 K052516STERITEC CONTAINER CORD - CI 135, STERITEC PROCESS INDICATOR LABELS - CI 140, STERITEC PROCESS INDICATOR DOTS - CI 137 K040901STERITEC EMU-GRAPH, MODEL NO. CI 131/US K024293BOWIE-DICK MINI PAK, MODEL BD 115 K012732INTEGRAPH FLASH, MODEL CI 110

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Related Devices (Code: JOJ)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.