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FDA 510(k)

EMIT 2000 VANCOMYCIN CALIBRATORS

K-Number: K020845 · 2002-05-08

ApplicantDade Behring, Inc.
Decision Date2002-05-08
Product CodeDLJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

EMIT 2000 VANCOMYCIN CALIBRATORS is the device name listed in this FDA 510(k) record. The listed applicant is Dade Behring, Inc.. It received FDA 510(k) clearance on 2002-05-08 under 510(k) number K020845. The device is classified under product code DLJ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMIT 2000 VANCOMYCIN CALIBRATORS?

EMIT 2000 VANCOMYCIN CALIBRATORS is a medical device that received FDA 510(k) clearance on 2002-05-08. The listed applicant is Dade Behring, Inc.. The 510(k) number is K020845.

When did EMIT 2000 VANCOMYCIN CALIBRATORS receive FDA 510(k) clearance?

EMIT 2000 VANCOMYCIN CALIBRATORS received FDA 510(k) clearance on 2002-05-08, under 510(k) number K020845.

Who is the listed applicant for EMIT 2000 VANCOMYCIN CALIBRATORS?

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

What is the FDA product code for EMIT 2000 VANCOMYCIN CALIBRATORS?

The FDA product code for EMIT 2000 VANCOMYCIN CALIBRATORS is DLJ.

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Other records listing Dade Behring, 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.

K093848PT-MULTI-CALIBRATOR, MODEL OPAT07K081161DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYSTK081249DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEMK071603DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA)K071597DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600K073604DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD

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Related Devices (Code: DLJ)

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.

K132090BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2Randox Laboratories, Ltd.K091617QMS LIDOCAINE CALIBRATORS, MODEL 0374678Thermo Fisher ScientificK082030DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440Siemens Healthcare Diagnostics, Inc.K062182DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520Dade Behring, Inc.K062199DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430)Dade Behring, Inc.K061503DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A)Dade Behring, 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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