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FDA 510(k)

HDL-C/LDL-C CALIBRATOR, MODEL 1913-003

K-Number: K993098 · 1999-10-08

ApplicantData Medical Associates, Inc.
Decision Date1999-10-08
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HDL-C/LDL-C CALIBRATOR, MODEL 1913-003 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 1999-10-08 under 510(k) number K993098. The device is classified under product code JIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HDL-C/LDL-C CALIBRATOR, MODEL 1913-003?

HDL-C/LDL-C CALIBRATOR, MODEL 1913-003 is a medical device that received FDA 510(k) clearance on 1999-10-08. The listed applicant is Data Medical Associates, Inc.. The 510(k) number is K993098.

When did HDL-C/LDL-C CALIBRATOR, MODEL 1913-003 receive FDA 510(k) clearance?

HDL-C/LDL-C CALIBRATOR, MODEL 1913-003 received FDA 510(k) clearance on 1999-10-08, under 510(k) number K993098.

Who is the listed applicant for HDL-C/LDL-C CALIBRATOR, MODEL 1913-003?

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 HDL-C/LDL-C CALIBRATOR, MODEL 1913-003?

The FDA product code for HDL-C/LDL-C CALIBRATOR, MODEL 1913-003 is JIX.

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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.

K971113DMA TRIGLYCERIDES PROCEDURESK961919DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDUREK955302SERUM BICARBONATE/CARBON DIOXIDEK955796IRON CALIBRATOR & CALIBRATION VERIFICATION SETK955300TOTAL BILIRUBIN PROCEDUREK952437DMA GLUCOSE HEXOKINASE U.V. PROCEDURE

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Related Devices (Code: JIX)

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.

K161140VITROS Chemistry Products Calibrator Kit 3Ortho-Clinical Diagnostics, Inc.K133330C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEINRoche DiagnosticsK130765ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL IIElitechgroupK123321DIMENSION CHEMISTRY III CALIBRATORYSiemens Healthcare DiagnosticsK123372ABBOTT LIPID MULTI CONSTITUENT CALIBRATORAbbott LaboratoriesK122398RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORSSiemens Healthcare Diagnostics, 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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