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FDA 510(k)

COAGUCHEK S SYSTEM, MODEL 2138280

K-Number: K994349 · 2000-09-06

ApplicantRoche Diagnostics Corp.
Decision Date2000-09-06
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COAGUCHEK S SYSTEM, MODEL 2138280 is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Corp.. It received FDA 510(k) clearance on 2000-09-06 under 510(k) number K994349. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COAGUCHEK S SYSTEM, MODEL 2138280?

COAGUCHEK S SYSTEM, MODEL 2138280 is a medical device that received FDA 510(k) clearance on 2000-09-06. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K994349.

When did COAGUCHEK S SYSTEM, MODEL 2138280 receive FDA 510(k) clearance?

COAGUCHEK S SYSTEM, MODEL 2138280 received FDA 510(k) clearance on 2000-09-06, under 510(k) number K994349.

Who is the listed applicant for COAGUCHEK S SYSTEM, MODEL 2138280?

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

What is the FDA product code for COAGUCHEK S SYSTEM, MODEL 2138280?

The FDA product code for COAGUCHEK S SYSTEM, MODEL 2138280 is JPA.

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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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