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FDA 510(k)

CONE-TROL LIQUID CHEMISTRY CONTROLS

K-Number: K121759 · 2012-07-24

ApplicantCone Bioproducts
Decision Date2012-07-24
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CONE-TROL LIQUID CHEMISTRY CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Cone Bioproducts. It received FDA 510(k) clearance on 2012-07-24 under 510(k) number K121759. 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 CONE-TROL LIQUID CHEMISTRY CONTROLS?

CONE-TROL LIQUID CHEMISTRY CONTROLS is a medical device that received FDA 510(k) clearance on 2012-07-24. The listed applicant is Cone Bioproducts. The 510(k) number is K121759.

When did CONE-TROL LIQUID CHEMISTRY CONTROLS receive FDA 510(k) clearance?

CONE-TROL LIQUID CHEMISTRY CONTROLS received FDA 510(k) clearance on 2012-07-24, under 510(k) number K121759.

Who is the listed applicant for CONE-TROL LIQUID CHEMISTRY CONTROLS?

The FDA 510(k) record lists Cone Bioproducts as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CONE-TROL LIQUID CHEMISTRY CONTROLS?

The FDA product code for CONE-TROL LIQUID CHEMISTRY CONTROLS is JJY.

Related Clinical Trials

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.

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Other records listing Cone Bioproducts 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.

K121534CONE-TROL HEMOGLOBIN A1C CONTROL SETK052010HBA1C LINEARITY SET

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

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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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