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FDA 510(k)

CIBA CORNING ACS VANCOMYCIN IMMUNOASSAY

K-Number: K951059 · 1995-06-19

ApplicantCiba Corning Diagnostics Corp.
Decision Date1995-06-19
Product CodeLEH
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

CIBA CORNING ACS VANCOMYCIN IMMUNOASSAY 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 1995-06-19 under 510(k) number K951059. The device is classified under product code LEH. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CIBA CORNING ACS VANCOMYCIN IMMUNOASSAY?

CIBA CORNING ACS VANCOMYCIN IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1995-06-19. The listed applicant is Ciba Corning Diagnostics Corp.. The 510(k) number is K951059.

When did CIBA CORNING ACS VANCOMYCIN IMMUNOASSAY receive FDA 510(k) clearance?

CIBA CORNING ACS VANCOMYCIN IMMUNOASSAY received FDA 510(k) clearance on 1995-06-19, under 510(k) number K951059.

Who is the listed applicant for CIBA CORNING ACS VANCOMYCIN IMMUNOASSAY?

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 ACS VANCOMYCIN IMMUNOASSAY?

The FDA product code for CIBA CORNING ACS VANCOMYCIN IMMUNOASSAY is LEH.

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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: LEH)

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.

K222439Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)Siemens Healthcare Diagnostics, Inc.K160202Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)Siemens Healthcare Diagnostics, Inc.K152245ONLINE TDM Vancomycin Gen.3Roche Diagnostics Operations (Rdo)K123947ARCHITECT IVANCOMYCINBiokit, S.A.K072036ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1P30-25 AND 1P30-01Biokit, S.A.K063045IMMULITE 2000, IMMULITE 2500 VANCOMYCINDiagnostic Products 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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