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FDA 510(k)

STC DIAGNOSTICS AUTO-LYTE BARBITURATES EIA

K-Number: K934376 · 1993-12-07

ApplicantSolarcare, Inc.
Decision Date1993-12-07
Product CodeDIS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

STC DIAGNOSTICS AUTO-LYTE BARBITURATES EIA is the device name listed in this FDA 510(k) record. The listed applicant is Solarcare, Inc.. It received FDA 510(k) clearance on 1993-12-07 under 510(k) number K934376. The device is classified under product code DIS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STC DIAGNOSTICS AUTO-LYTE BARBITURATES EIA?

STC DIAGNOSTICS AUTO-LYTE BARBITURATES EIA is a medical device that received FDA 510(k) clearance on 1993-12-07. The listed applicant is Solarcare, Inc.. The 510(k) number is K934376.

When did STC DIAGNOSTICS AUTO-LYTE BARBITURATES EIA receive FDA 510(k) clearance?

STC DIAGNOSTICS AUTO-LYTE BARBITURATES EIA received FDA 510(k) clearance on 1993-12-07, under 510(k) number K934376.

Who is the listed applicant for STC DIAGNOSTICS AUTO-LYTE BARBITURATES EIA?

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

What is the FDA product code for STC DIAGNOSTICS AUTO-LYTE BARBITURATES EIA?

The FDA product code for STC DIAGNOSTICS AUTO-LYTE BARBITURATES EIA is DIS.

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Other records listing Solarcare, 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.

K934775STC COCAINE METABOLITE EIAK944372STC DIAGNOSTIC AUTO-LYTE PROPOXYPHENE EIAK941496SOLARCARE TOTAL PROTEIN MICRO-PLATE ASSAYK941497SOLARCARE ALANINE AMINOTRANSFERASE MICRO-PLATE ASSAYK933327HISTOFREEZER

Related Devices (Code: DIS)

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.

K161714Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsImmunalysis CorporationK092268RANDOX BARITURATES ASSAYRandox Laboratories, Ltd.K110515UCP DRUG SCREENING TEST CUPSUcp Biosciences, Inc.K070098QUICKSCREEN BARBITURATE 300 SCREENING TEST, MODELS 9019, 9018; MULTI DRUG SCREENING TEST, MODEL 9317T; CUP MULTI DRUG SCPhamatech, Inc.K070009AT HOME DRUG TEST MODELS, 9308T AND 9308XPhamatech, Inc.K062165VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERSOrtho-Clinical Diagnostics

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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