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FDA 510(k)

NEISSERIA - KWIK PLUS

K-Number: K852998 · 1985-07-23

ApplicantMicro-Bio-Logics
Decision Date1985-07-23
Product CodeJSX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

NEISSERIA - KWIK PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Micro-Bio-Logics. It received FDA 510(k) clearance on 1985-07-23 under 510(k) number K852998. 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 - KWIK PLUS?

NEISSERIA - KWIK PLUS is a medical device that received FDA 510(k) clearance on 1985-07-23. The listed applicant is Micro-Bio-Logics. The 510(k) number is K852998.

When did NEISSERIA - KWIK PLUS receive FDA 510(k) clearance?

NEISSERIA - KWIK PLUS received FDA 510(k) clearance on 1985-07-23, under 510(k) number K852998.

Who is the listed applicant for NEISSERIA - KWIK PLUS?

The FDA 510(k) record lists Micro-Bio-Logics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEISSERIA - KWIK PLUS?

The FDA product code for NEISSERIA - KWIK PLUS is JSX.

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Other records listing Micro-Bio-Logics 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.

K870731LYFO KWIK(TM) RUS KITK861312LYFO-KWIK (TM) COAGULASE PLASMAK861022KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMSK855172KWI (TM) G-CO/TWOK855198INDI KWIK (TM) CO/TWO KITK851978LYFO-KWIK OMI KIT

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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.K870117NEISSERIA/BRANHAMELLA DIFFERENTIAL TESTPro-Lab, 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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