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FDA 510(k)

AMAX CS-190 COAGULATION ANALYZER SYSTEM

K-Number: K955720 · 1996-03-13

ApplicantSigma Diagnostics, Inc.
Decision Date1996-03-13
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

AMAX CS-190 COAGULATION ANALYZER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Diagnostics, Inc.. It received FDA 510(k) clearance on 1996-03-13 under 510(k) number K955720. 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 AMAX CS-190 COAGULATION ANALYZER SYSTEM?

AMAX CS-190 COAGULATION ANALYZER SYSTEM is a medical device that received FDA 510(k) clearance on 1996-03-13. The listed applicant is Sigma Diagnostics, Inc.. The 510(k) number is K955720.

When did AMAX CS-190 COAGULATION ANALYZER SYSTEM receive FDA 510(k) clearance?

AMAX CS-190 COAGULATION ANALYZER SYSTEM received FDA 510(k) clearance on 1996-03-13, under 510(k) number K955720.

Who is the listed applicant for AMAX CS-190 COAGULATION ANALYZER SYSTEM?

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

What is the FDA product code for AMAX CS-190 COAGULATION ANALYZER SYSTEM?

The FDA product code for AMAX CS-190 COAGULATION ANALYZER SYSTEM is JPA.

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Other records listing Sigma Diagnostics, 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.

K021162AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHEDK020109SIGMA DIAGNOSTICS ACCUCLOT LA CONTROLK013549SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971K013544SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096K013545SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221K012410INFINITY HBA KIT, MODELS 537-A, 537-B

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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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