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FDA 510(k)

NEISSERIA/BRANHAMELLA DIFFERENTIAL TEST

K-Number: K870117 · 1987-03-20

ApplicantPro-Lab, Inc.
Decision Date1987-03-20
Product CodeJSX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

NEISSERIA/BRANHAMELLA DIFFERENTIAL TEST is the device name listed in this FDA 510(k) record. The listed applicant is Pro-Lab, Inc.. It received FDA 510(k) clearance on 1987-03-20 under 510(k) number K870117. The device is classified under product code JSX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEISSERIA/BRANHAMELLA DIFFERENTIAL TEST?

NEISSERIA/BRANHAMELLA DIFFERENTIAL TEST is a medical device that received FDA 510(k) clearance on 1987-03-20. The listed applicant is Pro-Lab, Inc.. The 510(k) number is K870117.

When did NEISSERIA/BRANHAMELLA DIFFERENTIAL TEST receive FDA 510(k) clearance?

NEISSERIA/BRANHAMELLA DIFFERENTIAL TEST received FDA 510(k) clearance on 1987-03-20, under 510(k) number K870117.

Who is the listed applicant for NEISSERIA/BRANHAMELLA DIFFERENTIAL TEST?

The FDA 510(k) record lists Pro-Lab, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEISSERIA/BRANHAMELLA DIFFERENTIAL TEST?

The FDA product code for NEISSERIA/BRANHAMELLA DIFFERENTIAL TEST is JSX.

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Related Devices (Code: JSX)

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.

K960759GONOPOX TEST KITMedtex Laboratories, Inc.K923566NIZYME TEST KITRemel Co.K913456VISI-NEISSERIAKev Connecticut Diagnostics, Inc.K880511XACT NEISSERIAAustin Biological LaboratoriesK881501MODIFIED IDS RAPID NH SYSTEMInnovative Diagnostic Systems, Inc.K853544QUAD FERM +Analytical 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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