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FDA 510(k)

TOBRAMYCIN REAGENT TEST KIT

K-Number: K813391 · 1981-12-18

ApplicantBeckman Instruments, Inc.
Decision Date1981-12-18
Product CodeLKB
DecisionSubstantially Equivalent

Device Summary

TOBRAMYCIN REAGENT TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Instruments, Inc.. It received FDA 510(k) clearance on 1981-12-18 under 510(k) number K813391. The device is classified under product code LKB. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOBRAMYCIN REAGENT TEST KIT?

TOBRAMYCIN REAGENT TEST KIT is a medical device that received FDA 510(k) clearance on 1981-12-18. The listed applicant is Beckman Instruments, Inc.. The 510(k) number is K813391.

When did TOBRAMYCIN REAGENT TEST KIT receive FDA 510(k) clearance?

TOBRAMYCIN REAGENT TEST KIT received FDA 510(k) clearance on 1981-12-18, under 510(k) number K813391.

Who is the listed applicant for TOBRAMYCIN REAGENT TEST KIT?

The FDA 510(k) record lists Beckman Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TOBRAMYCIN REAGENT TEST KIT?

The FDA product code for TOBRAMYCIN REAGENT TEST KIT is LKB.

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Other records listing Beckman Instruments, Inc. 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.

K973448ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469K982250ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZERK981403IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENTK981354ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211K980173ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505K974816ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229

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Related Devices (Code: LKB)

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.

K121655BD ALCOHOL SWABBecton, Dickinson & COK112791SITESCRUB IPA DEVICEC. R. BardK912161I.V. STARR KITMedical Device Inspection Co., Inc.K912731STERI-SWABWestlock Investments (Usa), Inc.K910735HEXIDIS ALCOHOL SWABSpecialites SeptodontK896898BOWEN ELECTRODE SKIN PREPATORY CLEANSERBowen & Company, Inc.

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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