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FDA 510(k)

IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGE

K-Number: K013938 · 2002-01-28

ApplicantDiametrics Medical, Inc.
Decision Date2002-01-28
Product CodeKHP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IRMA SL BLOOD ANALYSIS SYSTEM LACTATE 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 2002-01-28 under 510(k) number K013938. The device is classified under product code KHP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGE?

IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGE is a medical device that received FDA 510(k) clearance on 2002-01-28. The listed applicant is Diametrics Medical, Inc.. The 510(k) number is K013938.

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

IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGE received FDA 510(k) clearance on 2002-01-28, under 510(k) number K013938.

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

The FDA product code for IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGE is KHP.

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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.

K030035IRMA SL BLOOD ANALYSIS SYSTEM CR 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

View all 7 devices →

Related Devices (Code: KHP)

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.

K130113PICCOLO LACTATE TEST SYSTEMAbaxis, Inc.K113216RAPIDPOINT 500 BLOOD GAS ANALYERSiemens Healthcare DiagnosticsK112955NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEMNova Biomedical CorporationK112430I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGEAbbott Pont of Care, Inc.K100602NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPSNova Biomedical Corp.K093297EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBEEpocal, 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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