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FDA 510(k)

ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON)

K-Number: K110394 · 2011-06-09

ApplicantVital Diagnostics (Manufacturing) Ptyltd
Decision Date2011-06-09
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON) is the device name listed in this FDA 510(k) record. The listed applicant is Vital Diagnostics (Manufacturing) Ptyltd. It received FDA 510(k) clearance on 2011-06-09 under 510(k) number K110394. 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 ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON)?

ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON) is a medical device that received FDA 510(k) clearance on 2011-06-09. The listed applicant is Vital Diagnostics (Manufacturing) Ptyltd. The 510(k) number is K110394.

When did ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON) receive FDA 510(k) clearance?

ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON) received FDA 510(k) clearance on 2011-06-09, under 510(k) number K110394.

Who is the listed applicant for ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON)?

The FDA 510(k) record lists Vital Diagnostics (Manufacturing) Ptyltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON)?

The FDA product code for ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON) is JIX.

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Other records listing Vital Diagnostics (Manufacturing) Ptyltd 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.

K120626EON CALCIUM REGENTK112416CPK REAGENTK111063VITAL SERUM CONTROLSK100060EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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