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FDA 510(k)

MULTICHEM U

K-Number: K131993 · 2013-10-15

ApplicantTechno-Path Manufacturing , Ltd.
Decision Date2013-10-15
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MULTICHEM U is the device name listed in this FDA 510(k) record. The listed applicant is Techno-Path Manufacturing , Ltd.. It received FDA 510(k) clearance on 2013-10-15 under 510(k) number K131993. 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 MULTICHEM U?

MULTICHEM U is a medical device that received FDA 510(k) clearance on 2013-10-15. The listed applicant is Techno-Path Manufacturing , Ltd.. The 510(k) number is K131993.

When did MULTICHEM U receive FDA 510(k) clearance?

MULTICHEM U received FDA 510(k) clearance on 2013-10-15, under 510(k) number K131993.

Who is the listed applicant for MULTICHEM U?

The FDA 510(k) record lists Techno-Path Manufacturing , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MULTICHEM U?

The FDA product code for MULTICHEM U is JJY.

Related Clinical Trials

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Other records listing Techno-Path Manufacturing , Ltd. 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.

K242492Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG); Multichem ID-GNeg (09339906190); Multichem ID-GNeg (SR102N); Multichem ID-GNeg (SR102MN)K132751MULTICHEM S PLUS / S PLUS (ASSAYED)K131992MULTICHEM PK132174MULTICHEM WBTK132091MULTICHEM IA AND IA PLUS

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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