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FDA 510(k)

VANCOMYCIN FLUORESCENT IMMUNOASSAY

K-Number: K822308 · 1982-08-16

ApplicantAmerican Diagnostic Corp.
Decision Date1982-08-16
Product CodeLEH
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

VANCOMYCIN FLUORESCENT IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is American Diagnostic Corp.. It received FDA 510(k) clearance on 1982-08-16 under 510(k) number K822308. 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 VANCOMYCIN FLUORESCENT IMMUNOASSAY?

VANCOMYCIN FLUORESCENT IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1982-08-16. The listed applicant is American Diagnostic Corp.. The 510(k) number is K822308.

When did VANCOMYCIN FLUORESCENT IMMUNOASSAY receive FDA 510(k) clearance?

VANCOMYCIN FLUORESCENT IMMUNOASSAY received FDA 510(k) clearance on 1982-08-16, under 510(k) number K822308.

Who is the listed applicant for VANCOMYCIN FLUORESCENT IMMUNOASSAY?

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

What is the FDA product code for VANCOMYCIN FLUORESCENT IMMUNOASSAY?

The FDA product code for VANCOMYCIN FLUORESCENT IMMUNOASSAY is LEH.

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Other records listing American Diagnostic Corp. as applicant

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K162589Adscope 658 Electronic StethoscopeK093495OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITSK060321ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BKK012304ADC 656 ELECTRONIC STETHOSCOPEK962655ANEROID AND MERCURIAL SPHYGMOMANOMETERSK940686ELECTRONIC THERMOMETERS

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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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