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FDA 510(k)

AMRESCO FLOW PAC CREATININE COLOR REAGENT 2310 &

K-Number: K853888 · 1985-10-15

ApplicantAmerican Research Products Co.
Decision Date1985-10-15
Product CodeCGX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMRESCO FLOW PAC CREATININE COLOR REAGENT 2310 & is the device name listed in this FDA 510(k) record. The listed applicant is American Research Products Co.. It received FDA 510(k) clearance on 1985-10-15 under 510(k) number K853888. The device is classified under product code CGX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMRESCO FLOW PAC CREATININE COLOR REAGENT 2310 &?

AMRESCO FLOW PAC CREATININE COLOR REAGENT 2310 & is a medical device that received FDA 510(k) clearance on 1985-10-15. The listed applicant is American Research Products Co.. The 510(k) number is K853888.

When did AMRESCO FLOW PAC CREATININE COLOR REAGENT 2310 & receive FDA 510(k) clearance?

AMRESCO FLOW PAC CREATININE COLOR REAGENT 2310 & received FDA 510(k) clearance on 1985-10-15, under 510(k) number K853888.

Who is the listed applicant for AMRESCO FLOW PAC CREATININE COLOR REAGENT 2310 &?

The FDA 510(k) record lists American Research Products Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMRESCO FLOW PAC CREATININE COLOR REAGENT 2310 &?

The FDA product code for AMRESCO FLOW PAC CREATININE COLOR REAGENT 2310 & is CGX.

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Other records listing American Research Products Co. as applicant

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Related Devices (Code: CGX)

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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