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FDA 510(k)

AVOCET PT

K-Number: K980839 · 1998-09-30

ApplicantAvocet Medical, Inc.
Decision Date1998-09-30
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

AVOCET PT is the device name listed in this FDA 510(k) record. The listed applicant is Avocet Medical, Inc.. It received FDA 510(k) clearance on 1998-09-30 under 510(k) number K980839. 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 AVOCET PT?

AVOCET PT is a medical device that received FDA 510(k) clearance on 1998-09-30. The listed applicant is Avocet Medical, Inc.. The 510(k) number is K980839.

When did AVOCET PT receive FDA 510(k) clearance?

AVOCET PT received FDA 510(k) clearance on 1998-09-30, under 510(k) number K980839.

Who is the listed applicant for AVOCET PT?

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

What is the FDA product code for AVOCET PT?

The FDA product code for AVOCET PT is JPA.

Related Clinical Trials

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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Other records listing Avocet Medical, Inc. 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.

K994006AVOCET ACUSURE (FOR PATIENT SELF-TESTING) AND AVOCET ACUSURE PRO (FOR PROFESSIONAL USE)K991286AVOCET ACUSURE SYSTEMK980982AVOCET SYSTEM LIQUID CONTROL LEVEL 1 AND LEVEL 2

Related Devices (Code: JPA)

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.

K253658STA Satellite Max®Diagnostica Stago, Inc.K250965Automated Blood Coagulation Analyzer CN-Series (CN-6000)Sysmex America, Inc.K251024TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeHaemoneticsK243858TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeHaemonetics CorporationK232018Citrated: K, KH, RTH, FFHHaemonetics CorporationK233790ACL TOP 970 CLInstrumentation Laboratory

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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