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FDA 510(k)

STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY

K-Number: K955905 · 1996-05-30

ApplicantSolarcare Technologies Corp,Inc.
Decision Date1996-05-30
Product CodeCEK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN 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 1996-05-30 under 510(k) number K955905. The device is classified under product code CEK. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY?

STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY is a medical device that received FDA 510(k) clearance on 1996-05-30. The listed applicant is Solarcare Technologies Corp,Inc.. The 510(k) number is K955905.

When did STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY receive FDA 510(k) clearance?

STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY received FDA 510(k) clearance on 1996-05-30, under 510(k) number K955905.

Who is the listed applicant for STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN 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 URINARY PROTEIN ASSAY?

The FDA product code for STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY is CEK.

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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 ASSAYK954158STC DIAGNOSTICS AUTO-LYTE PH ASSAYK940048STC DIAGNOSTICS PCP MICRO-PLATE EIA MODIFICATIONK954073STC DIAGNOSTICS LSD MICRO-PLATE EIAK954266STC DIAGNOSTICS AUTO-LYTE CREATININE ASSAY

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Related Devices (Code: CEK)

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.

K992846HICHEM TOTAL PROTEIN REAGENTElan Holdings, Inc.K973108TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50Diagnostic Chemicals , Ltd.K980042CARESIDE TOTAL PROTEINExigent Diagnostics, Inc.K971524TOTAL PROTEIN OR TPCarolina Liquid Chemistries Corp.K961864CSF/URINE TOTAL PROTEINTeco DiagnosticsK955936TOTAL PROTEIN REAGENTDerma Media Lab., Inc.

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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