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FDA 510(k)

OPACIDEN OPA REAGENT STRIPS

K-Number: K070419 · 2007-08-31

ApplicantHach Company
Decision Date2007-08-31
Product CodeJOJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

OPACIDEN OPA REAGENT STRIPS is the device name listed in this FDA 510(k) record. The listed applicant is Hach Company. It received FDA 510(k) clearance on 2007-08-31 under 510(k) number K070419. 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 OPACIDEN OPA REAGENT STRIPS?

OPACIDEN OPA REAGENT STRIPS is a medical device that received FDA 510(k) clearance on 2007-08-31. The listed applicant is Hach Company. The 510(k) number is K070419.

When did OPACIDEN OPA REAGENT STRIPS receive FDA 510(k) clearance?

OPACIDEN OPA REAGENT STRIPS received FDA 510(k) clearance on 2007-08-31, under 510(k) number K070419.

Who is the listed applicant for OPACIDEN OPA REAGENT STRIPS?

The FDA 510(k) record lists Hach Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPACIDEN OPA REAGENT STRIPS?

The FDA product code for OPACIDEN OPA REAGENT STRIPS is JOJ.

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Other records listing Hach Company 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.

K162471Hach CM130 Chlorine Monitoring SystemK042322STERICHEK BLOOD LEAK REAGENT STRIPSK040660STERICHEK GLUTARALDEHYDE REAGENT STRIPS

Related Devices (Code: JOJ)

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Official Source

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

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