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FDA 510(k)

STC DIAGNOSTICS AUTO-LYTE CREATININE ASSAY

K-Number: K954266 · 1995-10-13

ApplicantSolarcare Technologies Corp,Inc.
Decision Date1995-10-13
Product CodeCGX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

STC DIAGNOSTICS AUTO-LYTE CREATININE 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 1995-10-13 under 510(k) number K954266. The device is classified under product code CGX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STC DIAGNOSTICS AUTO-LYTE CREATININE ASSAY?

STC DIAGNOSTICS AUTO-LYTE CREATININE ASSAY is a medical device that received FDA 510(k) clearance on 1995-10-13. The listed applicant is Solarcare Technologies Corp,Inc.. The 510(k) number is K954266.

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

STC DIAGNOSTICS AUTO-LYTE CREATININE ASSAY received FDA 510(k) clearance on 1995-10-13, under 510(k) number K954266.

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

The FDA product code for STC DIAGNOSTICS AUTO-LYTE CREATININE ASSAY is CGX.

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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

View all 28 devices →

Related Devices (Code: CGX)

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.

K252206Nova Allegro UACR Assay, Nova Allegro AnalyzerNova Biomedical CorporationK251058Tru Kidney Health Test Panel; Tru AnalyzerTruvian HealthK242685Atellica® CH Creatinine_3 (Crea3)Siemens Healthcare Diagnostics, Inc.K221813Nova Allegro UACR Assay, Nova Allegro AnalyzerNova Biomedical CorporationK210452Creatinine2Abbott Ireland Diagnostics DivisionK161494Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)Siemens Healthcare Diagnostics, 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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