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FDA 510(k)

DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE

K-Number: K062316 · 2006-09-06

ApplicantDade Behring, Inc.
Decision Date2006-09-06
Product CodeJIF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE 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 2006-09-06 under 510(k) number K062316. The device is classified under product code JIF. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE?

DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE is a medical device that received FDA 510(k) clearance on 2006-09-06. The listed applicant is Dade Behring, Inc.. The 510(k) number is K062316.

When did DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE receive FDA 510(k) clearance?

DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE received FDA 510(k) clearance on 2006-09-06, under 510(k) number K062316.

Who is the listed applicant for DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE?

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 DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE?

The FDA product code for DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE is JIF.

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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: JIF)

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.

K183517Ammonia IIRoche Diagnostics Operations (Rdo)K123677DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL)Siemens Healthcare DiagnosticsK123320DIMENSION AMMONIA FLEX REAGENT CARTRIDGESiemens Healthcare DiagnosticsK051114SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAYSentinel Ch. SrlK033921AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10Diagnostic Chemicals , Ltd.K030873RANDOX AMMONIARandox Laboratories, 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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