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FDA 510(k)

ORTHO BACTERIURIA DETECTION SYS

K-Number: K833834 · 1984-03-12

ApplicantOrtho Diagnostic Systems, Inc.
Decision Date1984-03-12
Product CodeJXA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ORTHO BACTERIURIA DETECTION SYS 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 1984-03-12 under 510(k) number K833834. The device is classified under product code JXA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHO BACTERIURIA DETECTION SYS?

ORTHO BACTERIURIA DETECTION SYS is a medical device that received FDA 510(k) clearance on 1984-03-12. The listed applicant is Ortho Diagnostic Systems, Inc.. The 510(k) number is K833834.

When did ORTHO BACTERIURIA DETECTION SYS receive FDA 510(k) clearance?

ORTHO BACTERIURIA DETECTION SYS received FDA 510(k) clearance on 1984-03-12, under 510(k) number K833834.

Who is the listed applicant for ORTHO BACTERIURIA DETECTION SYS?

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 BACTERIURIA DETECTION SYS?

The FDA product code for ORTHO BACTERIURIA DETECTION SYS is JXA.

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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: JXA)

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.

K011043OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI)OsmetechK981084URISCREENDiatech Diagnostics,Inc.K972676URINE SCREENING DEVICECombact Diagnostic Systems , Ltd.K952246TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KITTri-Tech, Inc.K950257MULTIPLE (IZON DBS & URINE COLLECTION KIT)Izon Business Products, Inc.K950221MULTIPLE (IZON BLOOD & URINE COLLECTION KIT)Izon Business Products, 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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