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FDA 510(k)

KOAGULAB CTS CHROMOGRNIC TESTING SYSTEM

K-Number: K914188 · 1992-08-26

ApplicantOrtho Diagnostic Systems, Inc.
Decision Date1992-08-26
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

KOAGULAB CTS CHROMOGRNIC TESTING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1992-08-26 under 510(k) number K914188. 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 KOAGULAB CTS CHROMOGRNIC TESTING SYSTEM?

KOAGULAB CTS CHROMOGRNIC TESTING SYSTEM is a medical device that received FDA 510(k) clearance on 1992-08-26. The listed applicant is Ortho Diagnostic Systems, Inc.. The 510(k) number is K914188.

When did KOAGULAB CTS CHROMOGRNIC TESTING SYSTEM receive FDA 510(k) clearance?

KOAGULAB CTS CHROMOGRNIC TESTING SYSTEM received FDA 510(k) clearance on 1992-08-26, under 510(k) number K914188.

Who is the listed applicant for KOAGULAB CTS CHROMOGRNIC TESTING SYSTEM?

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

What is the FDA product code for KOAGULAB CTS CHROMOGRNIC TESTING SYSTEM?

The FDA product code for KOAGULAB CTS CHROMOGRNIC TESTING SYSTEM is JPA.

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Other records listing Ortho Diagnostic Systems, 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.

K951459ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATEK951632ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE)K964754ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERYTHRINE CONJUGATEK963902QUANTITATIVE FIBRINOGEN ASSAYK950568ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL ANTIBODY (MURINE)K950625ORTHO-MUNE OK-COMBO CD40FITC/CD8-PE (OKT4A/OKT8) MONOCLONAL ANTIBODY (MURINE)

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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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