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FDA 510(k)

NITRATE SWAB-RAPID TEST

K-Number: K800803 · 1980-07-08

ApplicantRemel Co.
Decision Date1980-07-08
Product CodeJXB
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

NITRATE SWAB-RAPID TEST is the device name listed in this FDA 510(k) record. The listed applicant is Remel Co.. It received FDA 510(k) clearance on 1980-07-08 under 510(k) number K800803. The device is classified under product code JXB. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NITRATE SWAB-RAPID TEST?

NITRATE SWAB-RAPID TEST is a medical device that received FDA 510(k) clearance on 1980-07-08. The listed applicant is Remel Co.. The 510(k) number is K800803.

When did NITRATE SWAB-RAPID TEST receive FDA 510(k) clearance?

NITRATE SWAB-RAPID TEST received FDA 510(k) clearance on 1980-07-08, under 510(k) number K800803.

Who is the listed applicant for NITRATE SWAB-RAPID TEST?

The FDA 510(k) record lists Remel Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NITRATE SWAB-RAPID TEST?

The FDA product code for NITRATE SWAB-RAPID TEST is JXB.

Related Clinical Trials

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Other records listing Remel Co. 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.

K013711BACTI-SWAB DRYK965149A.C.T. IK965150A.C.T. IVK965152A.C.T. IIK965151A.C.T. IIIK960095BACTIDROP CALCOFLUOR WHITE

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Related Devices (Code: JXB)

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.

K080719YEAST TRAFFIC LIGHT PNA FISHAdvandx, Inc.K062461C. ALBICANS PNA FISHAdvandx, Inc.K993554YEASTESTDiagnostic Markers, Inc.K943621RAPID YEAST PLUS SYSTEMInnovative Diagnostic Systems, Inc.K935124BACTICARD CANDIDARemel Co.K900112MICRORING YTMedical Wire & Equipment Co.

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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