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FDA 510(k)

IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE

K-Number: K011586 · 2001-11-16

ApplicantDiametrics Medical, Inc.
Decision Date2001-11-16
Product CodeGAA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IRMA SL BLOOD ANALYSIS SYSTEM GL 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 2001-11-16 under 510(k) number K011586. The device is classified under product code GAA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE?

IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE is a medical device that received FDA 510(k) clearance on 2001-11-16. The listed applicant is Diametrics Medical, Inc.. The 510(k) number is K011586.

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

IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE received FDA 510(k) clearance on 2001-11-16, under 510(k) number K011586.

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

The FDA product code for IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE is GAA.

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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 CARTRIDGEK013938IRMA SL BLOOD ANALYSIS SYSTEM LACTATE 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: GAA)

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.

K223625CapnoSpot™ Pneumothorax Decompression IndicatorPneumeric, Inc.K102274ARVIK LAPAROSCOPIC ASPIRATION INSTRUMENTArvik Enterprises/ Mini Lap TechnologiesK994151PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICESXimed/Prosure/InjectxK983200INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEXXimed/Prosure/InjectxK974741MANAN ACCURA NEEDLEMedical Device Technologies, Inc.K962425BONOPTY COAXIAL BONE BIOPSY SYSTEM WITH ECCENTRIC DRILL(10-1072,3,4)Radi Medical Systems AB

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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