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FDA 510(k)

TOBRAMYCIN FLUORESCENT IMMUNOASSAY

K-Number: K813542 · 1982-01-12

ApplicantAmerican Diagnostic Corp.
Decision Date1982-01-12
Product CodeLCR
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

TOBRAMYCIN 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 1982-01-12 under 510(k) number K813542. The device is classified under product code LCR. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOBRAMYCIN FLUORESCENT IMMUNOASSAY?

TOBRAMYCIN FLUORESCENT IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1982-01-12. The listed applicant is American Diagnostic Corp.. The 510(k) number is K813542.

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

TOBRAMYCIN FLUORESCENT IMMUNOASSAY received FDA 510(k) clearance on 1982-01-12, under 510(k) number K813542.

Who is the listed applicant for TOBRAMYCIN 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 TOBRAMYCIN FLUORESCENT IMMUNOASSAY?

The FDA product code for TOBRAMYCIN FLUORESCENT IMMUNOASSAY is LCR.

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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: LCR)

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.

K060998QMS TOBRAMYCINSeradyn, Inc.K974029ACS TOBRAMYCINChiron Diagnostics Corp.K962818TOBRAMYCIN FLEX REAGENT CARTRIDGEDade Intl., Inc.K952568BECKMAN ARRAY TOBRAMYCIN (TOB) REAGENTBeckman Instruments, Inc.K911940OPUS(R) TOBRAMYCINPb Diagnostic Systems, Inc.K911613VAR AURAL GROM AG/S9,SD8.00.28.5/0.2 NS/S/6823 1.4Exmoor Plastics , Ltd.

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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