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FDA 510(k)

CIBA CORNING CERTAIN LYTE

K-Number: K894576 · 1989-10-30

ApplicantCiba Corning Diagnostics Corp.
Decision Date1989-10-30
Product CodeJJR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CIBA CORNING CERTAIN LYTE is the device name listed in this FDA 510(k) record. The listed applicant is Ciba Corning Diagnostics Corp.. It received FDA 510(k) clearance on 1989-10-30 under 510(k) number K894576. The device is classified under product code JJR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CIBA CORNING CERTAIN LYTE?

CIBA CORNING CERTAIN LYTE is a medical device that received FDA 510(k) clearance on 1989-10-30. The listed applicant is Ciba Corning Diagnostics Corp.. The 510(k) number is K894576.

When did CIBA CORNING CERTAIN LYTE receive FDA 510(k) clearance?

CIBA CORNING CERTAIN LYTE received FDA 510(k) clearance on 1989-10-30, under 510(k) number K894576.

Who is the listed applicant for CIBA CORNING CERTAIN LYTE?

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

What is the FDA product code for CIBA CORNING CERTAIN LYTE?

The FDA product code for CIBA CORNING CERTAIN LYTE is JJR.

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Other records listing Ciba Corning Diagnostics Corp. 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.

K962559ACS CORTISOL IMMUNOASSAYK963251CIBA CORNING ACS;180 DPD ASSAYK961807CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4K961657CIBA CORNING 400 SYSTEMK962021CIBA CORNING 348 SYSTEMK962126ACS CKMB II IMMUNOASSAY

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Related Devices (Code: JJR)

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.

K990971EASYLYTE QUALITY CONTROL KIT, MODELS 2814, 2815, 2816Medica Corp.K960592ELECTROLYTE STANDARDSPhoenix Diagnostics, Inc.K955630RNA MEDICAL HEMAT CONTROLBionostics, Inc.K951435AALTO SCIENTIFIC SWEAT CHLORIDE REFERENCE MATERIALAalto Scientific, Ltd.K943925SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTINGQuantimetrix Corp.K934641I-STAT CONTROL LEVELS 1,2,3I-Stat 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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