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FDA 510(k)

POLY-CHEM CREATININE

K-Number: K061944 · 2006-11-03

ApplicantPolymedco, Inc.
Decision Date2006-11-03
Product CodeJFY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

POLY-CHEM CREATININE is the device name listed in this FDA 510(k) record. The listed applicant is Polymedco, Inc.. It received FDA 510(k) clearance on 2006-11-03 under 510(k) number K061944. The device is classified under product code JFY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLY-CHEM CREATININE?

POLY-CHEM CREATININE is a medical device that received FDA 510(k) clearance on 2006-11-03. The listed applicant is Polymedco, Inc.. The 510(k) number is K061944.

When did POLY-CHEM CREATININE receive FDA 510(k) clearance?

POLY-CHEM CREATININE received FDA 510(k) clearance on 2006-11-03, under 510(k) number K061944.

Who is the listed applicant for POLY-CHEM CREATININE?

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

What is the FDA product code for POLY-CHEM CREATININE?

The FDA product code for POLY-CHEM CREATININE is JFY.

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Other records listing Polymedco, Inc. as applicant

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Related Devices (Code: JFY)

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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