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FDA 510(k)

RAPIDTEG TEG-ACT TEST

K-Number: K062604 · 2007-01-31

ApplicantHaemoscope Corp.
Decision Date2007-01-31
Product CodeJBP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

RAPIDTEG TEG-ACT TEST is the device name listed in this FDA 510(k) record. The listed applicant is Haemoscope Corp.. It received FDA 510(k) clearance on 2007-01-31 under 510(k) number K062604. The device is classified under product code JBP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAPIDTEG TEG-ACT TEST?

RAPIDTEG TEG-ACT TEST is a medical device that received FDA 510(k) clearance on 2007-01-31. The listed applicant is Haemoscope Corp.. The 510(k) number is K062604.

When did RAPIDTEG TEG-ACT TEST receive FDA 510(k) clearance?

RAPIDTEG TEG-ACT TEST received FDA 510(k) clearance on 2007-01-31, under 510(k) number K062604.

Who is the listed applicant for RAPIDTEG TEG-ACT TEST?

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

What is the FDA product code for RAPIDTEG TEG-ACT TEST?

The FDA product code for RAPIDTEG TEG-ACT TEST is JBP.

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Other records listing Haemoscope 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.

K041502THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAYK002177THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIESK993678THROMBELASTOGRAPH COAGULATION ANALYZER TEG - 5000 SERIESK954437THROMBELASTOGRAPH COAGULATION ANALYZER 3000SK904204THROMBELASTOGRAPHK895844THROMBELASTOGRAPH(R)

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Related Devices (Code: JBP)

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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