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FDA 510(k)

KOAGULAB* 32-S COAGULATION SYSTEM

K-Number: K885035 · 1989-02-03

ApplicantOrtho Diagnostic Systems, Inc.
Decision Date1989-02-03
Product CodeGKP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

KOAGULAB* 32-S COAGULATION 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 1989-02-03 under 510(k) number K885035. The device is classified under product code GKP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KOAGULAB* 32-S COAGULATION SYSTEM?

KOAGULAB* 32-S COAGULATION SYSTEM is a medical device that received FDA 510(k) clearance on 1989-02-03. The listed applicant is Ortho Diagnostic Systems, Inc.. The 510(k) number is K885035.

When did KOAGULAB* 32-S COAGULATION SYSTEM receive FDA 510(k) clearance?

KOAGULAB* 32-S COAGULATION SYSTEM received FDA 510(k) clearance on 1989-02-03, under 510(k) number K885035.

Who is the listed applicant for KOAGULAB* 32-S COAGULATION 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* 32-S COAGULATION SYSTEM?

The FDA product code for KOAGULAB* 32-S COAGULATION SYSTEM is GKP.

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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 ASSAYK950625ORTHO-MUNE OK-COMBO CD40FITC/CD8-PE (OKT4A/OKT8) MONOCLONAL ANTIBODY (MURINE)K950568ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL ANTIBODY (MURINE)

View all 126 devices →

Related Devices (Code: GKP)

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.

K242127ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS)Instrumentation Laboratory (IL) Co.K231031ACL TOP Family 70 SeriesInstrumentation Laboratory CompanyK160276ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS)Instrumentation Laboratory COK091980ACL TOP 700 LASInstrumentation Laboratory COK073377ACL TOP (WITH SYSTEM SOFTWARE V3.0.0)Instrumentation Laboratory COK063679ACL TOPInstrumentation Laboratory CO

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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