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FDA 510(k)

SMART READ BIOLOGICAL TEST PACK

K-Number: K103000 · 2011-02-11

ApplicantSteritec Products Mfg Co, Inc.
Decision Date2011-02-11
Product CodeJOJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SMART READ BIOLOGICAL TEST PACK is the device name listed in this FDA 510(k) record. The listed applicant is Steritec Products Mfg Co, Inc.. It received FDA 510(k) clearance on 2011-02-11 under 510(k) number K103000. 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 SMART READ BIOLOGICAL TEST PACK?

SMART READ BIOLOGICAL TEST PACK is a medical device that received FDA 510(k) clearance on 2011-02-11. The listed applicant is Steritec Products Mfg Co, Inc.. The 510(k) number is K103000.

When did SMART READ BIOLOGICAL TEST PACK receive FDA 510(k) clearance?

SMART READ BIOLOGICAL TEST PACK received FDA 510(k) clearance on 2011-02-11, under 510(k) number K103000.

Who is the listed applicant for SMART READ BIOLOGICAL TEST PACK?

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

What is the FDA product code for SMART READ BIOLOGICAL TEST PACK?

The FDA product code for SMART READ BIOLOGICAL TEST PACK is JOJ.

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Other records listing Steritec Products Mfg Co, 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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