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FDA 510(k)

IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL LIFESCAN SURESTEP PRO BLOOD GLUCOSE MODULE

K-Number: K974396 · 1997-12-18

ApplicantDiametrics Medical, Inc.
Decision Date1997-12-18
Product CodeCHL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL LIFESCAN SURESTEP PRO BLOOD GLUCOSE MODULE 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 1997-12-18 under 510(k) number K974396. The device is classified under product code CHL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL LIFESCAN SURESTEP PRO BLOOD GLUCOSE MODULE?

IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL LIFESCAN SURESTEP PRO BLOOD GLUCOSE MODULE is a medical device that received FDA 510(k) clearance on 1997-12-18. The listed applicant is Diametrics Medical, Inc.. The 510(k) number is K974396.

When did IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL LIFESCAN SURESTEP PRO BLOOD GLUCOSE MODULE receive FDA 510(k) clearance?

IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL LIFESCAN SURESTEP PRO BLOOD GLUCOSE MODULE received FDA 510(k) clearance on 1997-12-18, under 510(k) number K974396.

Who is the listed applicant for IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL LIFESCAN SURESTEP PRO BLOOD GLUCOSE MODULE?

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 BLOOD ANALYSIS SYSTEM WITH OPTIONAL LIFESCAN SURESTEP PRO BLOOD GLUCOSE MODULE?

The FDA product code for IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL LIFESCAN SURESTEP PRO BLOOD GLUCOSE MODULE is CHL.

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Other records listing Diametrics Medical, Inc. as applicant

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K030035IRMA SL BLOOD ANALYSIS SYSTEM CR CARTRIDGEK013938IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGEK011586IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGEK981270IRMA BLOOD ANALYSIS SYSTEMK980523IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL MULTI-USE CARTRIDGEK945240IRMA BLOOD ANALYSIS SYSTEM

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Related Devices (Code: CHL)

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.

K252207ABL90 FLEX PLUS System, safeCLINITUBESRadiometer Medicals ApsK244014i-STAT CG4+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K240998ABL90 FLEX PLUS SystemRadiometer Medicals ApsK230285i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K221900Stat Profile Prime Plus Analyzer SystemNova Biomedical CorporationK223857i-STAT G3+ cartridge with the i-STAT 1 SystemAbbott Point of Care, 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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