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FDA 510(k)

CYCLOSPORIN A (WHOLE BLOOD) CONTROL - LEVELS 1,2,3

K-Number: K864456 · 1987-05-06

ApplicantCala Diagnostics
Decision Date1987-05-06
Product CodeLAS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

CYCLOSPORIN A (WHOLE BLOOD) CONTROL - LEVELS 1,2,3 is the device name listed in this FDA 510(k) record. The listed applicant is Cala Diagnostics. It received FDA 510(k) clearance on 1987-05-06 under 510(k) number K864456. 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 CYCLOSPORIN A (WHOLE BLOOD) CONTROL - LEVELS 1,2,3?

CYCLOSPORIN A (WHOLE BLOOD) CONTROL - LEVELS 1,2,3 is a medical device that received FDA 510(k) clearance on 1987-05-06. The listed applicant is Cala Diagnostics. The 510(k) number is K864456.

When did CYCLOSPORIN A (WHOLE BLOOD) CONTROL - LEVELS 1,2,3 receive FDA 510(k) clearance?

CYCLOSPORIN A (WHOLE BLOOD) CONTROL - LEVELS 1,2,3 received FDA 510(k) clearance on 1987-05-06, under 510(k) number K864456.

Who is the listed applicant for CYCLOSPORIN A (WHOLE BLOOD) CONTROL - LEVELS 1,2,3?

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

What is the FDA product code for CYCLOSPORIN A (WHOLE BLOOD) CONTROL - LEVELS 1,2,3?

The FDA product code for CYCLOSPORIN A (WHOLE BLOOD) CONTROL - LEVELS 1,2,3 is LAS.

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Other records listing Cala 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.

K944247CARDIOCHEX CKMB IMMUNOINHIBITION CONTROLK944246CARDIOCHEX CKMB MASS MEASUREMENT CONTROLK944243CARDIOCHEXK930874LD-1 CONTROL-LEVEL 1 & 2K930875CKMB CONTROL - LEVEL 1,2,3K930873CKMB ISOENZYME CONTROL-LEVEL 1,2.3

View all 12 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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