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FDA 510(k)

IRON QVET

K-Number: K943029 · 1994-12-02

ApplicantPrisma Systems
Decision Date1994-12-02
Product CodeJIY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IRON QVET is the device name listed in this FDA 510(k) record. The listed applicant is Prisma Systems. It received FDA 510(k) clearance on 1994-12-02 under 510(k) number K943029. The device is classified under product code JIY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IRON QVET?

IRON QVET is a medical device that received FDA 510(k) clearance on 1994-12-02. The listed applicant is Prisma Systems. The 510(k) number is K943029.

When did IRON QVET receive FDA 510(k) clearance?

IRON QVET received FDA 510(k) clearance on 1994-12-02, under 510(k) number K943029.

Who is the listed applicant for IRON QVET?

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

What is the FDA product code for IRON QVET?

The FDA product code for IRON QVET is JIY.

Other records listing Prisma Systems 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.

K950177CK QVETK943027CHOLESTEROL QVETK943001MAGNESIUM QVETK942964LACTATE DEHYDROGENASE QVETK943042BUN QVETK942997ALKALINE PHOSPHATASE (ALKP) QVET

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Related Devices (Code: JIY)

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.

K061793DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATORDade Behring, Inc.K060264DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85)Dade Behring, Inc.K051115SENTINEL IRON LIQUIDSentinel Ch. SrlK033983VITALAB IRON REAGENTClinical Data, Inc.K030528ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL)Clinical DataK020816IRON-PC-SL ASSAY MODEL # 151-10, 151-26Diagnostic Chemicals , 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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