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FDA 510(k)

ORTHO* CHLAMYDIA ANTIGEN ELISA TEST & TRANSPORT

K-Number: K863490 · 1986-11-05

ApplicantOrtho Diagnostic Systems, Inc.
Decision Date1986-11-05
Product CodeLJC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ORTHO* CHLAMYDIA ANTIGEN ELISA TEST & TRANSPORT 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 1986-11-05 under 510(k) number K863490. The device is classified under product code LJC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHO* CHLAMYDIA ANTIGEN ELISA TEST & TRANSPORT?

ORTHO* CHLAMYDIA ANTIGEN ELISA TEST & TRANSPORT is a medical device that received FDA 510(k) clearance on 1986-11-05. The listed applicant is Ortho Diagnostic Systems, Inc.. The 510(k) number is K863490.

When did ORTHO* CHLAMYDIA ANTIGEN ELISA TEST & TRANSPORT receive FDA 510(k) clearance?

ORTHO* CHLAMYDIA ANTIGEN ELISA TEST & TRANSPORT received FDA 510(k) clearance on 1986-11-05, under 510(k) number K863490.

Who is the listed applicant for ORTHO* CHLAMYDIA ANTIGEN ELISA TEST & TRANSPORT?

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* CHLAMYDIA ANTIGEN ELISA TEST & TRANSPORT?

The FDA product code for ORTHO* CHLAMYDIA ANTIGEN ELISA TEST & TRANSPORT is LJC.

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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: LJC)

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.

K032330CT OIAThermo Biostar, Inc.K033865IDEIA PCE CHLAMYDIADakocytomation, Ltd.K033079CHLAMYDIA IGG ELISA TEST SYSTEMTrinity Biotech USAK982210MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIADade Behring, Inc.K962558CHLAMYDIA IGG ELISA TEST SYSTEMArmkel, LLCK960850ACCESS CHLAMYDIA ASSAYBio-Rad 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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