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FDA 510(k)

IMMULITE 2000, IMMULITE 2500 VANCOMYCIN

K-Number: K063045 · 2006-12-05

ApplicantDiagnostic Products Corp.
Decision Date2006-12-05
Product CodeLEH
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

IMMULITE 2000, IMMULITE 2500 VANCOMYCIN is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Products Corp.. It received FDA 510(k) clearance on 2006-12-05 under 510(k) number K063045. 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 IMMULITE 2000, IMMULITE 2500 VANCOMYCIN?

IMMULITE 2000, IMMULITE 2500 VANCOMYCIN is a medical device that received FDA 510(k) clearance on 2006-12-05. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K063045.

When did IMMULITE 2000, IMMULITE 2500 VANCOMYCIN receive FDA 510(k) clearance?

IMMULITE 2000, IMMULITE 2500 VANCOMYCIN received FDA 510(k) clearance on 2006-12-05, under 510(k) number K063045.

Who is the listed applicant for IMMULITE 2000, IMMULITE 2500 VANCOMYCIN?

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

What is the FDA product code for IMMULITE 2000, IMMULITE 2500 VANCOMYCIN?

The FDA product code for IMMULITE 2000, IMMULITE 2500 VANCOMYCIN is LEH.

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Other records listing Diagnostic Products 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.

K034055IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN IK033234IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZERK032881IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONEK023152IMMULITE 2000 ALLERGEN-SPECIFIC IGEK023304IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCLK022603IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER

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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.K060586ENZYME IMMUNOASSAY, VANCOMYCINRoche Diagnostics 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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