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FDA 510(k)

IRMA SL BLOOD ANALYSIS SYSTEM CR CARTRIDGE

K-Number: K030035 · 2003-06-25

ApplicantDiametrics Medical, Inc.
Decision Date2003-06-25
Product CodeJFY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IRMA SL BLOOD ANALYSIS SYSTEM CR CARTRIDGE is the device name listed in this FDA 510(k) record. The listed applicant is Diametrics Medical, Inc.. It received FDA 510(k) clearance on 2003-06-25 under 510(k) number K030035. The device is classified under product code JFY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IRMA SL BLOOD ANALYSIS SYSTEM CR CARTRIDGE?

IRMA SL BLOOD ANALYSIS SYSTEM CR CARTRIDGE is a medical device that received FDA 510(k) clearance on 2003-06-25. The listed applicant is Diametrics Medical, Inc.. The 510(k) number is K030035.

When did IRMA SL BLOOD ANALYSIS SYSTEM CR CARTRIDGE receive FDA 510(k) clearance?

IRMA SL BLOOD ANALYSIS SYSTEM CR CARTRIDGE received FDA 510(k) clearance on 2003-06-25, under 510(k) number K030035.

Who is the listed applicant for IRMA SL BLOOD ANALYSIS SYSTEM CR CARTRIDGE?

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

What is the FDA product code for IRMA SL BLOOD ANALYSIS SYSTEM CR CARTRIDGE?

The FDA product code for IRMA SL BLOOD ANALYSIS SYSTEM CR CARTRIDGE is JFY.

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Other records listing Diametrics Medical, 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.

K013938IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGEK011586IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGEK981270IRMA BLOOD ANALYSIS SYSTEMK980523IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL MULTI-USE CARTRIDGEK974396IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL LIFESCAN SURESTEP PRO BLOOD GLUCOSE MODULEK945240IRMA BLOOD ANALYSIS SYSTEM

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Related Devices (Code: JFY)

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.

K252619QSCHECK UISACRQstag, Inc.K212223Atellica CH Enzymatic Creatinine_3 (ECre3)Siemens Healthcare Diagnostics, Inc.K193649Yumizen C1200 Creatinine PAPHORIBA ABX SASK182384ACR LAB Urine Analysis Test SystemHealthy.Io, Ltd.K183555GEM Premier ChemSTATInstrumentation Laboratory COK182038URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzerYd Diagnostics Corporation

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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