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FDA 510(k)

STC DIAGNOSTICS AUTO-LYTE BENZODIAZEPINES EIA

K-Number: K934869 · 1993-11-22

ApplicantSolarcare Technologies Corp,Inc.
Decision Date1993-11-22
Product CodeJXM
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

STC DIAGNOSTICS AUTO-LYTE BENZODIAZEPINES EIA 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 1993-11-22 under 510(k) number K934869. The device is classified under product code JXM. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STC DIAGNOSTICS AUTO-LYTE BENZODIAZEPINES EIA?

STC DIAGNOSTICS AUTO-LYTE BENZODIAZEPINES EIA is a medical device that received FDA 510(k) clearance on 1993-11-22. The listed applicant is Solarcare Technologies Corp,Inc.. The 510(k) number is K934869.

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

STC DIAGNOSTICS AUTO-LYTE BENZODIAZEPINES EIA received FDA 510(k) clearance on 1993-11-22, under 510(k) number K934869.

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

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 BENZODIAZEPINES EIA?

The FDA product code for STC DIAGNOSTICS AUTO-LYTE BENZODIAZEPINES EIA is JXM.

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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: JXM)

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.

K243498Alinity c Benzodiazepines Reagent KitMicrogenics CorporationK221765ONLINE DAT Benzodiazepines IIRoche DiagnosticsK190968CEDIA Benzodiazepine AssayMicrogenics CorporationK173963DRI Benzodiazepine AssayMicrogenics CorporationK163590Psychemedics Microplate EIA for Benzodiazepines in HairPsychemedics CorporationK163704Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip CardHealgen Scientific,, LLC

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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