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FDA 510(k)

STC DIAGNOSTICS AUTO-LYTE(TM) ETHYL ALCOHOL ASSAY

K-Number: K931516 · 1993-07-19

ApplicantSolarcare Technologies Corp,Inc.
Decision Date1993-07-19
Product CodeDIC
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

STC DIAGNOSTICS AUTO-LYTE(TM) ETHYL ALCOHOL ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Solarcare Technologies Corp,Inc.. It received FDA 510(k) clearance on 1993-07-19 under 510(k) number K931516. 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 STC DIAGNOSTICS AUTO-LYTE(TM) ETHYL ALCOHOL ASSAY?

STC DIAGNOSTICS AUTO-LYTE(TM) ETHYL ALCOHOL ASSAY is a medical device that received FDA 510(k) clearance on 1993-07-19. The listed applicant is Solarcare Technologies Corp,Inc.. The 510(k) number is K931516.

When did STC DIAGNOSTICS AUTO-LYTE(TM) ETHYL ALCOHOL ASSAY receive FDA 510(k) clearance?

STC DIAGNOSTICS AUTO-LYTE(TM) ETHYL ALCOHOL ASSAY received FDA 510(k) clearance on 1993-07-19, under 510(k) number K931516.

Who is the listed applicant for STC DIAGNOSTICS AUTO-LYTE(TM) ETHYL ALCOHOL ASSAY?

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

What is the FDA product code for STC DIAGNOSTICS AUTO-LYTE(TM) ETHYL ALCOHOL ASSAY?

The FDA product code for STC DIAGNOSTICS AUTO-LYTE(TM) ETHYL ALCOHOL ASSAY is DIC.

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Other records listing Solarcare Technologies Corp,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.

K954326STC DIAGNOSTICS AUTO-LYTE URINARY HEMOGLOBIN ASSAYK954156STC DIAGNOSTICS AUTO-LYTE URINARY LEUKOCYTE ESTERASE ASSAYK955905STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAYK954158STC DIAGNOSTICS AUTO-LYTE PH ASSAYK940048STC DIAGNOSTICS PCP MICRO-PLATE EIA MODIFICATIONK954073STC DIAGNOSTICS LSD MICRO-PLATE EIA

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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.K121256ALCO-SCREEN 02Chematics, Inc.K111005ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIALMedica Corp.K111206TECO DIAGNOSTICS SALIVA ALCOHOL TESTTeco Diagnostics

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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