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FDA 510(k)

STANBIO MAGNESIUM TEST SET, CAT. NO 0130

K-Number: K883170 · 1989-02-07

ApplicantStanbio Laboratory
Decision Date1989-02-07
Product CodeJGJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

STANBIO MAGNESIUM TEST SET, CAT. NO 0130 is the device name listed in this FDA 510(k) record. The listed applicant is Stanbio Laboratory. It received FDA 510(k) clearance on 1989-02-07 under 510(k) number K883170. 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 STANBIO MAGNESIUM TEST SET, CAT. NO 0130?

STANBIO MAGNESIUM TEST SET, CAT. NO 0130 is a medical device that received FDA 510(k) clearance on 1989-02-07. The listed applicant is Stanbio Laboratory. The 510(k) number is K883170.

When did STANBIO MAGNESIUM TEST SET, CAT. NO 0130 receive FDA 510(k) clearance?

STANBIO MAGNESIUM TEST SET, CAT. NO 0130 received FDA 510(k) clearance on 1989-02-07, under 510(k) number K883170.

Who is the listed applicant for STANBIO MAGNESIUM TEST SET, CAT. NO 0130?

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

What is the FDA product code for STANBIO MAGNESIUM TEST SET, CAT. NO 0130?

The FDA product code for STANBIO MAGNESIUM TEST SET, CAT. NO 0130 is JGJ.

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Other records listing Stanbio Laboratory 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.

K090093STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEMK081719STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEMK050266DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLORK050283CREATININE LIQUICOLORK042169STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZERK041155WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY

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Related Devices (Code: JGJ)

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.

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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