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FDA 510(k)

PTS Professional Chemistry Kit

K-Number: K182781 · 2018-12-21

ApplicantPolymer Technology Systems, Inc. D/B/A Pts Diagnostics
Decision Date2018-12-21
Product CodeCGA
Advisory CommitteeCH
DecisionUnknown

Device Summary

PTS Professional Chemistry Kit is the device name listed in this FDA 510(k) record. The listed applicant is Polymer Technology Systems, Inc. D/B/A Pts Diagnostics. It received FDA 510(k) clearance on 2018-12-21 under 510(k) number K182781. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the PTS Professional Chemistry Kit?

PTS Professional Chemistry Kit is a medical device that received FDA 510(k) clearance on 2018-12-21. The listed applicant is Polymer Technology Systems, Inc. D/B/A Pts Diagnostics. The 510(k) number is K182781.

When did PTS Professional Chemistry Kit receive FDA 510(k) clearance?

PTS Professional Chemistry Kit received FDA 510(k) clearance on 2018-12-21, under 510(k) number K182781.

Who is the listed applicant for PTS Professional Chemistry Kit?

The FDA 510(k) record lists Polymer Technology Systems, Inc. D/B/A Pts Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PTS Professional Chemistry Kit?

The FDA product code for PTS Professional Chemistry Kit is CGA.

Other records listing Polymer Technology Systems, Inc. D/B/A Pts Diagnostics 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.

K193406CardioChek Plus Test System; CardioChek Plus Home Test SystemK162282CardioChek Plus Test System, CardioChek Home Test System

Related Devices (Code: CGA)

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.

K252488ABL90 FLEX PLUS SystemRadiometer Medicals ApsK210933YSI 2900C Biochemistry AnalyzerYsi, Inc.K220328EasyStat 300Medica CorporationK223179Cholestech LDX ™ SystemAlere San Diego, Inc.K223755i-STAT G cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K223710i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, 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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