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FDA 510(k)

STC COCAINE METABOLITE EIA

K-Number: K934775 · 1995-07-14

ApplicantSolarcare, Inc.
Decision Date1995-07-14
Product CodeDIO
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

STC COCAINE METABOLITE 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 1995-07-14 under 510(k) number K934775. The device is classified under product code DIO. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STC COCAINE METABOLITE EIA?

STC COCAINE METABOLITE EIA is a medical device that received FDA 510(k) clearance on 1995-07-14. The listed applicant is Solarcare, Inc.. The 510(k) number is K934775.

When did STC COCAINE METABOLITE EIA receive FDA 510(k) clearance?

STC COCAINE METABOLITE EIA received FDA 510(k) clearance on 1995-07-14, under 510(k) number K934775.

Who is the listed applicant for STC COCAINE METABOLITE 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 COCAINE METABOLITE EIA?

The FDA product code for STC COCAINE METABOLITE EIA is DIO.

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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.

K944372STC DIAGNOSTIC AUTO-LYTE PROPOXYPHENE EIAK941496SOLARCARE TOTAL PROTEIN MICRO-PLATE ASSAYK941497SOLARCARE ALANINE AMINOTRANSFERASE MICRO-PLATE ASSAYK934376STC DIAGNOSTICS AUTO-LYTE BARBITURATES EIAK933327HISTOFREEZER

Related Devices (Code: DIO)

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.

K213211Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test SystemCarolina Liquid Chemistries Corp.K211973DRI Cocaine Metabolite AssayMicrogenics CorporationK191638Pointe Scientific Cocaine Metabolite Enzyme ImmunoassayMedtest DXK181499DRI Cocaine Metabolite AssayMicrogenics CorporationK170293Emit II Plus Cocaine Metabolite AssaySiemens Healthcare Diagnostics, Inc.K163570Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)Carolina Liquid Chemistries Corporation

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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