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FDA 510(k)

CYCLOSPORINE (WHOLE BLOOD) CONTROL-PEDIATRIC LEVEL

K-Number: K932662 · 1993-07-26

ApplicantMore Diagnostics
Decision Date1993-07-26
Product CodeLAS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

CYCLOSPORINE (WHOLE BLOOD) CONTROL-PEDIATRIC LEVEL is the device name listed in this FDA 510(k) record. The listed applicant is More Diagnostics. It received FDA 510(k) clearance on 1993-07-26 under 510(k) number K932662. The device is classified under product code LAS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CYCLOSPORINE (WHOLE BLOOD) CONTROL-PEDIATRIC LEVEL?

CYCLOSPORINE (WHOLE BLOOD) CONTROL-PEDIATRIC LEVEL is a medical device that received FDA 510(k) clearance on 1993-07-26. The listed applicant is More Diagnostics. The 510(k) number is K932662.

When did CYCLOSPORINE (WHOLE BLOOD) CONTROL-PEDIATRIC LEVEL receive FDA 510(k) clearance?

CYCLOSPORINE (WHOLE BLOOD) CONTROL-PEDIATRIC LEVEL received FDA 510(k) clearance on 1993-07-26, under 510(k) number K932662.

Who is the listed applicant for CYCLOSPORINE (WHOLE BLOOD) CONTROL-PEDIATRIC LEVEL?

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

What is the FDA product code for CYCLOSPORINE (WHOLE BLOOD) CONTROL-PEDIATRIC LEVEL?

The FDA product code for CYCLOSPORINE (WHOLE BLOOD) CONTROL-PEDIATRIC LEVEL is LAS.

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Other records listing More Diagnostics 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.

K072257MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVELK050125RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4K982845CARDIAC MARKERS CONTROL (SINGLE USE)-LEVELS, 1,2,3, MODELS NUMBER 175-1, 175-2, 175-3K980331IMMUNOSUPPRESSANT (WHOLE BLOOD) CONTROL, LEVEL 1 250-1, IMMUNOSUPPRESSANT (WHOLE BLOOS) CONTROL, LEVEL 2, 250-2, IMMUN\SK972976CARDIAC MARKERS CONTROL - LEVEL 1, LEVEL 2, LEVEL 3, TRI-LEVELK970778LEAD CONTROL (WHOLE BLOOD) LEVELS 1,2,3,4

View all 16 devices →

Related Devices (Code: LAS)

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.

K080459CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLSChromsystems Instruments & Chemicals GmbHK072257MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVELMore DiagnosticsK062942QUANTIMETRIX NICOSURE COTININE URINE CONTROLQuantimetrix Corp.K051074MAS IMMUNOSUPPRESSANT CONTROLSMicrogenics Corp.K040411DRI OXYCODONE ASSAYMicrogenics Corp.K032842MICROGENICS CYCLOSPORINE CONTROL KITMicrogenics Corp.

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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