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FDA 510(k)

INSTANT READOUT CHEMICAL INTEGRATOR CHALLENGE PACK, MODEL LT- 105

K-Number: K080136 · 2008-08-15

ApplicantSteritec Products, Inc.
Decision Date2008-08-15
Product CodeJOJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INSTANT READOUT CHEMICAL INTEGRATOR CHALLENGE PACK, MODEL LT- 105 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 2008-08-15 under 510(k) number K080136. 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 INSTANT READOUT CHEMICAL INTEGRATOR CHALLENGE PACK, MODEL LT- 105?

INSTANT READOUT CHEMICAL INTEGRATOR CHALLENGE PACK, MODEL LT- 105 is a medical device that received FDA 510(k) clearance on 2008-08-15. The listed applicant is Steritec Products, Inc.. The 510(k) number is K080136.

When did INSTANT READOUT CHEMICAL INTEGRATOR CHALLENGE PACK, MODEL LT- 105 receive FDA 510(k) clearance?

INSTANT READOUT CHEMICAL INTEGRATOR CHALLENGE PACK, MODEL LT- 105 received FDA 510(k) clearance on 2008-08-15, under 510(k) number K080136.

Who is the listed applicant for INSTANT READOUT CHEMICAL INTEGRATOR CHALLENGE PACK, MODEL LT- 105?

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 INSTANT READOUT CHEMICAL INTEGRATOR CHALLENGE PACK, MODEL LT- 105?

The FDA product code for INSTANT READOUT CHEMICAL INTEGRATOR CHALLENGE PACK, MODEL LT- 105 is JOJ.

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Other records listing Steritec Products, Inc. as applicant

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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.

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