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FDA 510(k)

COAG-A-MATE(R) XC

K-Number: K870960 · 1987-03-17

ApplicantOrganon Teknika Corp.
Decision Date1987-03-17
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COAG-A-MATE(R) XC is the device name listed in this FDA 510(k) record. The listed applicant is Organon Teknika Corp.. It received FDA 510(k) clearance on 1987-03-17 under 510(k) number K870960. 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 COAG-A-MATE(R) XC?

COAG-A-MATE(R) XC is a medical device that received FDA 510(k) clearance on 1987-03-17. The listed applicant is Organon Teknika Corp.. The 510(k) number is K870960.

When did COAG-A-MATE(R) XC receive FDA 510(k) clearance?

COAG-A-MATE(R) XC received FDA 510(k) clearance on 1987-03-17, under 510(k) number K870960.

Who is the listed applicant for COAG-A-MATE(R) XC?

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

What is the FDA product code for COAG-A-MATE(R) XC?

The FDA product code for COAG-A-MATE(R) XC is JPA.

Other records listing Organon Teknika Corp. as applicant

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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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