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FDA 510(k)

Multichem IA Plus

K-Number: K162530 · 2017-03-31

ApplicantTechno-Path Manufacturing
Decision Date2017-03-31
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Multichem IA Plus is the device name listed in this FDA 510(k) record. The listed applicant is Techno-Path Manufacturing. It received FDA 510(k) clearance on 2017-03-31 under 510(k) number K162530. 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 IA Plus?

Multichem IA Plus is a medical device that received FDA 510(k) clearance on 2017-03-31. The listed applicant is Techno-Path Manufacturing. The 510(k) number is K162530.

When did Multichem IA Plus receive FDA 510(k) clearance?

Multichem IA Plus received FDA 510(k) clearance on 2017-03-31, under 510(k) number K162530.

Who is the listed applicant for Multichem IA Plus?

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

What is the FDA product code for Multichem IA Plus?

The FDA product code for Multichem IA Plus is JJY.

Other records listing Techno-Path Manufacturing 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)

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.

K163629Audit 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.

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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