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FDA 510(k)

ALCO-SCREEN 02

K-Number: K121256 · 2012-09-12

ApplicantChematics, Inc.
Decision Date2012-09-12
Product CodeDIC
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ALCO-SCREEN 02 is the device name listed in this FDA 510(k) record. The listed applicant is Chematics, Inc.. It received FDA 510(k) clearance on 2012-09-12 under 510(k) number K121256. The device is classified under product code DIC. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALCO-SCREEN 02?

ALCO-SCREEN 02 is a medical device that received FDA 510(k) clearance on 2012-09-12. The listed applicant is Chematics, Inc.. The 510(k) number is K121256.

When did ALCO-SCREEN 02 receive FDA 510(k) clearance?

ALCO-SCREEN 02 received FDA 510(k) clearance on 2012-09-12, under 510(k) number K121256.

Who is the listed applicant for ALCO-SCREEN 02?

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

What is the FDA product code for ALCO-SCREEN 02?

The FDA product code for ALCO-SCREEN 02 is DIC.

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 Chematics, Inc. 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.

K121247ALCO-SCREEN

Related Devices (Code: DIC)

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.

K250609Sober Self-TestSober Ip, LLCK181553Immunalysis Ethyl Alcohol Enzyme AssayImmunalysis CorporationK121247ALCO-SCREENChematics, Inc.K111005ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIALMedica Corp.K111206TECO DIAGNOSTICS SALIVA ALCOHOL TESTTeco DiagnosticsK092273RANDOX ETHANOL ASSAYRandox 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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