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FDA 510(k)

MAGNESIUM PROCEDURE

K-Number: K861668 · 1986-05-27

ApplicantData Medical Associates, Inc.
Decision Date1986-05-27
Product CodeJGJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MAGNESIUM PROCEDURE is the device name listed in this FDA 510(k) record. The listed applicant is Data Medical Associates, Inc.. It received FDA 510(k) clearance on 1986-05-27 under 510(k) number K861668. 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 MAGNESIUM PROCEDURE?

MAGNESIUM PROCEDURE is a medical device that received FDA 510(k) clearance on 1986-05-27. The listed applicant is Data Medical Associates, Inc.. The 510(k) number is K861668.

When did MAGNESIUM PROCEDURE receive FDA 510(k) clearance?

MAGNESIUM PROCEDURE received FDA 510(k) clearance on 1986-05-27, under 510(k) number K861668.

Who is the listed applicant for MAGNESIUM PROCEDURE?

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

What is the FDA product code for MAGNESIUM PROCEDURE?

The FDA product code for MAGNESIUM PROCEDURE is JGJ.

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Other records listing Data Medical Associates, 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.

K993098HDL-C/LDL-C CALIBRATOR, MODEL 1913-003K971113DMA TRIGLYCERIDES PROCEDURESK961919DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDUREK955302SERUM BICARBONATE/CARBON DIOXIDEK955796IRON CALIBRATOR & CALIBRATION VERIFICATION SETK955300TOTAL BILIRUBIN PROCEDURE

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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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