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FDA 510(k)

EON CALCIUM REGENT

K-Number: K120626 · 2012-08-22

ApplicantVital Diagnostics (Manufacturing) Ptyltd
Decision Date2012-08-22
Product CodeCJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EON CALCIUM REGENT 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 2012-08-22 under 510(k) number K120626. The device is classified under product code CJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EON CALCIUM REGENT?

EON CALCIUM REGENT is a medical device that received FDA 510(k) clearance on 2012-08-22. The listed applicant is Vital Diagnostics (Manufacturing) Ptyltd. The 510(k) number is K120626.

When did EON CALCIUM REGENT receive FDA 510(k) clearance?

EON CALCIUM REGENT received FDA 510(k) clearance on 2012-08-22, under 510(k) number K120626.

Who is the listed applicant for EON CALCIUM REGENT?

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 EON CALCIUM REGENT?

The FDA product code for EON CALCIUM REGENT is CJY.

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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.

K112416CPK REAGENTK111063VITAL SERUM CONTROLSK110394ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON)K100060EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475

Related Devices (Code: CJY)

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.

K244042Calcium2Abbott IrelandK191396Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine JaffeHORIBA ABX SASK182042Randox Calcium (Ca)Randox Laboratories, Ltd.K123171ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONTHORIBA ABX SASK083386ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL), P/N 02189915 (70 ML FILL)Siemens Healthcare DiagnosticsK072356S-TEST CAAlfa Wassermann Diagnostic Technologies, 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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