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FDA 510(k)

ORTHO CLG IMMUNE COMPLEX TEST SYSTEM

K-Number: K821806 · 1982-06-25

ApplicantOrtho Diagnostic Systems, Inc.
Decision Date1982-06-25
Product CodeDAK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ORTHO CLG IMMUNE COMPLEX TEST 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 1982-06-25 under 510(k) number K821806. The device is classified under product code DAK. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHO CLG IMMUNE COMPLEX TEST SYSTEM?

ORTHO CLG IMMUNE COMPLEX TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1982-06-25. The listed applicant is Ortho Diagnostic Systems, Inc.. The 510(k) number is K821806.

When did ORTHO CLG IMMUNE COMPLEX TEST SYSTEM receive FDA 510(k) clearance?

ORTHO CLG IMMUNE COMPLEX TEST SYSTEM received FDA 510(k) clearance on 1982-06-25, under 510(k) number K821806.

Who is the listed applicant for ORTHO CLG IMMUNE COMPLEX TEST 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 ORTHO CLG IMMUNE COMPLEX TEST SYSTEM?

The FDA product code for ORTHO CLG IMMUNE COMPLEX TEST SYSTEM is DAK.

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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: DAK)

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.

K031563BINDAZYME CLQ CIC EIA KITThe Binding Site, Ltd.K032254IBL C1Q-CIC CIA TESTIbl GmbHK012576CIC-C1Q EIAAmerican Laboratory Products Co., Ltd.K973203THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODIESSangstat Medical Corp.K972873IMMUSTRIP HAMA IGGImmunomedics, Inc.K951968HUMAN C1Q RADIAL IMMUNODIFFUSION KITKent Laboratories, Inc.

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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