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FDA 510(k)

IN-VITRO DIAGNOSTIC REAGENT SET

K-Number: K930074 · 1993-05-11

ApplicantHorizon Diagnostics, Inc.
Decision Date1993-05-11
Product CodeJGJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IN-VITRO DIAGNOSTIC REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Horizon Diagnostics, Inc.. It received FDA 510(k) clearance on 1993-05-11 under 510(k) number K930074. The device is classified under product code JGJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IN-VITRO DIAGNOSTIC REAGENT SET?

IN-VITRO DIAGNOSTIC REAGENT SET is a medical device that received FDA 510(k) clearance on 1993-05-11. The listed applicant is Horizon Diagnostics, Inc.. The 510(k) number is K930074.

When did IN-VITRO DIAGNOSTIC REAGENT SET receive FDA 510(k) clearance?

IN-VITRO DIAGNOSTIC REAGENT SET received FDA 510(k) clearance on 1993-05-11, under 510(k) number K930074.

Who is the listed applicant for IN-VITRO DIAGNOSTIC REAGENT SET?

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

What is the FDA product code for IN-VITRO DIAGNOSTIC REAGENT SET?

The FDA product code for IN-VITRO DIAGNOSTIC REAGENT SET is JGJ.

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Other records listing Horizon Diagnostics, 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.

K971566CREATINE KINASE-MB REAGENT SETK933722HORIZON DIAGNOSTICS TRIGLYCERIDES-GPO REAGENTK935712IRON/TIBC REAGENTK930678AMYLASEK934533BUN-300/BUN-500 UREA NITROGEN REAGENTK930679DIRECT BILIRUBIN

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Related Devices (Code: JGJ)

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K181748MagnesiumAbbott LaboratoriesK173294MagnesiumAbbott LaboratoriesK162200Randox RX Daytona Plus Magnesium (MG)Randox Laboratories, Ltd.K162399Atellica CH Magnesium (Mg)Siemens Healthcare Diagnostics, Inc.K122302ACE MAGNESIUM REGENTAlfa Wassermann Diagnostics Technologies, LLCK111915MAGNESIUM ASSAYSekisui Diagnostics P.E.I., 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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