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FDA 510(k)

CLINITEK ATLAS AUTOMATED URINE CHEMISTRY SYSTEM

K-Number: K932674 · 1993-08-19

ApplicantMiles Inc., Dental Products
Decision Date1993-08-19
Product CodeKQO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CLINITEK ATLAS AUTOMATED URINE CHEMISTRY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Miles Inc., Dental Products. It received FDA 510(k) clearance on 1993-08-19 under 510(k) number K932674. 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 CLINITEK ATLAS AUTOMATED URINE CHEMISTRY SYSTEM?

CLINITEK ATLAS AUTOMATED URINE CHEMISTRY SYSTEM is a medical device that received FDA 510(k) clearance on 1993-08-19. The listed applicant is Miles Inc., Dental Products. The 510(k) number is K932674.

When did CLINITEK ATLAS AUTOMATED URINE CHEMISTRY SYSTEM receive FDA 510(k) clearance?

CLINITEK ATLAS AUTOMATED URINE CHEMISTRY SYSTEM received FDA 510(k) clearance on 1993-08-19, under 510(k) number K932674.

Who is the listed applicant for CLINITEK ATLAS AUTOMATED URINE CHEMISTRY SYSTEM?

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

What is the FDA product code for CLINITEK ATLAS AUTOMATED URINE CHEMISTRY SYSTEM?

The FDA product code for CLINITEK ATLAS AUTOMATED URINE CHEMISTRY SYSTEM 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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Other records listing Miles Inc., Dental Products 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.

K933360GLUMA 3 STEP BONDING SYSTEM/ GLUMA 3 PRIMER/DESENSITIZER

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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