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FDA 510(k)

HAEMOPHILUS IDENTIFICATION TEST KIT

K-Number: K833963 · 1983-12-30

ApplicantRemel Co.
Decision Date1983-12-30
Product CodeJTO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

HAEMOPHILUS IDENTIFICATION TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Remel Co.. It received FDA 510(k) clearance on 1983-12-30 under 510(k) number K833963. The device is classified under product code JTO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HAEMOPHILUS IDENTIFICATION TEST KIT?

HAEMOPHILUS IDENTIFICATION TEST KIT is a medical device that received FDA 510(k) clearance on 1983-12-30. The listed applicant is Remel Co.. The 510(k) number is K833963.

When did HAEMOPHILUS IDENTIFICATION TEST KIT receive FDA 510(k) clearance?

HAEMOPHILUS IDENTIFICATION TEST KIT received FDA 510(k) clearance on 1983-12-30, under 510(k) number K833963.

Who is the listed applicant for HAEMOPHILUS IDENTIFICATION TEST KIT?

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 HAEMOPHILUS IDENTIFICATION TEST KIT?

The FDA product code for HAEMOPHILUS IDENTIFICATION TEST KIT is JTO.

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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 DRYK965151A.C.T. IIIK965150A.C.T. IVK965152A.C.T. IIK965149A.C.T. IK960090CALCOFLUOR WHITE STAIN KIT

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Related Devices (Code: JTO)

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.

K050352IN-VITRO DIAGNOSTIC VAGINITIS TEST KITAmeritek Research, LLCK970832PYR SWABRemel, Inc.K970834GRAM SWABRemel, Inc.K970833INDOLE SWABRemel, Inc.K970009LYFO(TM) DIFFERENTIAL DISK-BACITRACINMicrobiologics, Inc.K962966IDS RAPID CB PLUS SYSTEMInnovative Diagnostic Systems, 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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