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FDA 510(k)

STERICHEK BLOOD LEAK REAGENT STRIPS

K-Number: K042322 · 2004-12-07

ApplicantHach Company
Decision Date2004-12-07
Product CodeFJD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

STERICHEK BLOOD LEAK 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 2004-12-07 under 510(k) number K042322. The device is classified under product code FJD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERICHEK BLOOD LEAK REAGENT STRIPS?

STERICHEK BLOOD LEAK REAGENT STRIPS is a medical device that received FDA 510(k) clearance on 2004-12-07. The listed applicant is Hach Company. The 510(k) number is K042322.

When did STERICHEK BLOOD LEAK REAGENT STRIPS receive FDA 510(k) clearance?

STERICHEK BLOOD LEAK REAGENT STRIPS received FDA 510(k) clearance on 2004-12-07, under 510(k) number K042322.

Who is the listed applicant for STERICHEK BLOOD LEAK 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 STERICHEK BLOOD LEAK REAGENT STRIPS?

The FDA product code for STERICHEK BLOOD LEAK REAGENT STRIPS is FJD.

Related Clinical Trials

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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 SystemK070419OPACIDEN OPA REAGENT STRIPSK040660STERICHEK GLUTARALDEHYDE REAGENT STRIPS

Related Devices (Code: FJD)

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.

K123805E-Z CHEK BLOOD LEAK TEST STRIPSReprocessing Products CorpK012115SERIM BLOOD LEAK TEST STRIP-2Serim Research Corp.K990206SERIM BLOOD LEAK TEST STRIPSerim Research Corp.

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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