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FDA 510(k)

UA PERFECT AUTOMATED ANALYSIS ASSAY FOR UROBILLINOGEN IN URINE

K-Number: K954514 · 1996-06-21

ApplicantSciteck Diagnostics, Inc.
Decision Date1996-06-21
Product CodeKQO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

UA PERFECT AUTOMATED ANALYSIS ASSAY FOR UROBILLINOGEN IN URINE is the device name listed in this FDA 510(k) record. The listed applicant is Sciteck Diagnostics, Inc.. It received FDA 510(k) clearance on 1996-06-21 under 510(k) number K954514. The device is classified under product code KQO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UA PERFECT AUTOMATED ANALYSIS ASSAY FOR UROBILLINOGEN IN URINE?

UA PERFECT AUTOMATED ANALYSIS ASSAY FOR UROBILLINOGEN IN URINE is a medical device that received FDA 510(k) clearance on 1996-06-21. The listed applicant is Sciteck Diagnostics, Inc.. The 510(k) number is K954514.

When did UA PERFECT AUTOMATED ANALYSIS ASSAY FOR UROBILLINOGEN IN URINE receive FDA 510(k) clearance?

UA PERFECT AUTOMATED ANALYSIS ASSAY FOR UROBILLINOGEN IN URINE received FDA 510(k) clearance on 1996-06-21, under 510(k) number K954514.

Who is the listed applicant for UA PERFECT AUTOMATED ANALYSIS ASSAY FOR UROBILLINOGEN IN URINE?

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

What is the FDA product code for UA PERFECT AUTOMATED ANALYSIS ASSAY FOR UROBILLINOGEN IN URINE?

The FDA product code for UA PERFECT AUTOMATED ANALYSIS ASSAY FOR UROBILLINOGEN IN URINE is KQO.

Related Clinical Trials

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.

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Related Devices (Code: KQO)

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.

K121456AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROLArkray, Inc.K102188CYBOW READER, MODELS 300 & 720DFI Co., Ltd.K101852CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KITIris International Inc., A Division of Iris Iris IK091472URITEST 50 AND URITEST 500 URINE ANALYZERArj Medical, Inc.K093555COBAS U411 TEST SYSTEMRoche DiagnosticsK093098AUTION MAX MODEL AX-4030 URINALYSIS SYSTEMArkray, Inc.

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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