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FDA 510(k)

DANA REUSABLE BI TEST PACK

K-Number: K130135 · 2013-11-25

ApplicantDana Products, Inc.
Decision Date2013-11-25
Product CodeJOJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DANA REUSABLE BI TEST PACK is the device name listed in this FDA 510(k) record. The listed applicant is Dana Products, Inc.. It received FDA 510(k) clearance on 2013-11-25 under 510(k) number K130135. 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 DANA REUSABLE BI TEST PACK?

DANA REUSABLE BI TEST PACK is a medical device that received FDA 510(k) clearance on 2013-11-25. The listed applicant is Dana Products, Inc.. The 510(k) number is K130135.

When did DANA REUSABLE BI TEST PACK receive FDA 510(k) clearance?

DANA REUSABLE BI TEST PACK received FDA 510(k) clearance on 2013-11-25, under 510(k) number K130135.

Who is the listed applicant for DANA REUSABLE BI TEST PACK?

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

What is the FDA product code for DANA REUSABLE BI TEST PACK?

The FDA product code for DANA REUSABLE BI TEST PACK is JOJ.

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Other records listing Dana Products, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K120592DANA REUSABLE BOWIE TEST PACK FOR DANA BOWIE DICK INDICATORSK110253REUSABLE TEST PACK FOR DANA EMULATING INDICATORSK103321DANA REUSABLE TESTPACK FOR STEAM STERILIZATION FOR 10 MINUTE EXTENDED CYCLESK100891DANA EMULATING INDICATORK102761DANA REUSABLE TEST PACK FOR STEAM STERILIZATIONK092944DANA REUSABLE TEST PACK FOR STEAM STERILIZATION

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Related Devices (Code: JOJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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