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FDA 510(k)

NEISSERIA-KWIK

K-Number: K811412 · 1981-06-16

ApplicantWindsor Laboratories, Inc.
Decision Date1981-06-16
Product CodeJSX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

NEISSERIA-KWIK is the device name listed in this FDA 510(k) record. The listed applicant is Windsor Laboratories, Inc.. It received FDA 510(k) clearance on 1981-06-16 under 510(k) number K811412. 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?

NEISSERIA-KWIK is a medical device that received FDA 510(k) clearance on 1981-06-16. The listed applicant is Windsor Laboratories, Inc.. The 510(k) number is K811412.

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

NEISSERIA-KWIK received FDA 510(k) clearance on 1981-06-16, under 510(k) number K811412.

Who is the listed applicant for NEISSERIA-KWIK?

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

What is the FDA product code for NEISSERIA-KWIK?

The FDA product code for NEISSERIA-KWIK is JSX.

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Other records listing Windsor Laboratories, 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.

K873281CARBAMAZEPINE (FPIA) CALIBRATOR KITK873282CARBAMAZEPINE FPIA FLUORES. POLARIZA. IMMUNOASSAYK871486(FPIA) ASSAY BUFFERK870389DIGOXIN (FPIA) CALIBRATOR KITK870390PHENOBARBITAL (FPIA) CALIBRATOR KITK864333DIGOXIN FPIA FLUORESCENCE POLARIZATION IMMUNOASSAY

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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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