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FDA 510(k)

CA-1000 AUTOMATED COAGULATION ANALYZER

K-Number: K931149 · 1993-11-03

ApplicantToa Medical Electronics USA, Inc.
Decision Date1993-11-03
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CA-1000 AUTOMATED COAGULATION ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Toa Medical Electronics USA, Inc.. It received FDA 510(k) clearance on 1993-11-03 under 510(k) number K931149. 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 CA-1000 AUTOMATED COAGULATION ANALYZER?

CA-1000 AUTOMATED COAGULATION ANALYZER is a medical device that received FDA 510(k) clearance on 1993-11-03. The listed applicant is Toa Medical Electronics USA, Inc.. The 510(k) number is K931149.

When did CA-1000 AUTOMATED COAGULATION ANALYZER receive FDA 510(k) clearance?

CA-1000 AUTOMATED COAGULATION ANALYZER received FDA 510(k) clearance on 1993-11-03, under 510(k) number K931149.

Who is the listed applicant for CA-1000 AUTOMATED COAGULATION ANALYZER?

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

What is the FDA product code for CA-1000 AUTOMATED COAGULATION ANALYZER?

The FDA product code for CA-1000 AUTOMATED COAGULATION ANALYZER is JPA.

Related Clinical Trials

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Other records listing Toa Medical Electronics USA, 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.

K936023SYSMEX SE-9000 AUTOMATED HEMATOLOGY ANALYZERK933886TOA MEDICAL ELECTRONICS CA-5000K920544SYSMEX HEMATOLOGY SYSTEM ACCESSORIESK914744SYSMEX NE-1500, MODIFICATIONK912494SYSMEX(TM) R-3000 AUTOMATED RETICULOCYTE ANALYZERK910849SYSMEX F-810

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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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