Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

COAG-A-MATE MAX

K-Number: K991101 · 1999-06-01

Decision Date1999-06-01
Product CodeGKP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COAG-A-MATE MAX 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 1999-06-01 under 510(k) number K991101. The device is classified under product code GKP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COAG-A-MATE MAX?

COAG-A-MATE MAX is a medical device that received FDA 510(k) clearance on 1999-06-01. The listed applicant is Organon Teknika Corp.. The 510(k) number is K991101.

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

COAG-A-MATE MAX received FDA 510(k) clearance on 1999-06-01, under 510(k) number K991101.

Who is the listed applicant for COAG-A-MATE MAX?

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 MAX?

The FDA product code for COAG-A-MATE MAX is GKP.

Other records listing Organon Teknika Corp. 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.

View all 130 devices →

Related Devices (Code: GKP)

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.

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.

↑