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FDA 510(k)

VITAL SERUM CONTROLS

K-Number: K111063 · 2011-06-28

ApplicantVital Diagnostics (Manufacturing) Ptyltd
Decision Date2011-06-28
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VITAL SERUM CONTROLS 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 2011-06-28 under 510(k) number K111063. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITAL SERUM CONTROLS?

VITAL SERUM CONTROLS is a medical device that received FDA 510(k) clearance on 2011-06-28. The listed applicant is Vital Diagnostics (Manufacturing) Ptyltd. The 510(k) number is K111063.

When did VITAL SERUM CONTROLS receive FDA 510(k) clearance?

VITAL SERUM CONTROLS received FDA 510(k) clearance on 2011-06-28, under 510(k) number K111063.

Who is the listed applicant for VITAL SERUM CONTROLS?

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 VITAL SERUM CONTROLS?

The FDA product code for VITAL SERUM CONTROLS is JJY.

Related Clinical Trials

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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 REAGENTK110394ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON)K100060EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475

Related Devices (Code: JJY)

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.

K162530Multichem IA PlusTechno-Path ManufacturingK163629Audit MicroControls Linearity FD Tumor Markers IIAalto Scientific, Ltd.K163015Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPakBio-Rad LaboratoriesK153712VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification KitRadiometer America, Inc.K132227LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAYBio-Rad LaboratoriesK132156RANDOX CSF CONTROLS LEVELS 2 AND 3Randox Laboratories, Ltd.

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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