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FDA 510(k)

STRATUS TOBRAMYCIN FLUOROMETRIC ENZYM

K-Number: K832408 · 1983-08-26

ApplicantAmerican Dade
Decision Date1983-08-26
Product CodeLCR
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

STRATUS TOBRAMYCIN FLUOROMETRIC ENZYM is the device name listed in this FDA 510(k) record. The listed applicant is American Dade. It received FDA 510(k) clearance on 1983-08-26 under 510(k) number K832408. 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 STRATUS TOBRAMYCIN FLUOROMETRIC ENZYM?

STRATUS TOBRAMYCIN FLUOROMETRIC ENZYM is a medical device that received FDA 510(k) clearance on 1983-08-26. The listed applicant is American Dade. The 510(k) number is K832408.

When did STRATUS TOBRAMYCIN FLUOROMETRIC ENZYM receive FDA 510(k) clearance?

STRATUS TOBRAMYCIN FLUOROMETRIC ENZYM received FDA 510(k) clearance on 1983-08-26, under 510(k) number K832408.

Who is the listed applicant for STRATUS TOBRAMYCIN FLUOROMETRIC ENZYM?

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

What is the FDA product code for STRATUS TOBRAMYCIN FLUOROMETRIC ENZYM?

The FDA product code for STRATUS TOBRAMYCIN FLUOROMETRIC ENZYM is LCR.

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Other records listing American Dade 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.

K873051STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAYK873171STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAYK873052STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAYK872789PARAMAX URINE/CSF CALIBRATORK872195DATA-FI DIMERTEST LATEX ASSAYK872196AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III

View all 149 devices →

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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