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FDA 510(k)

STAT PROFILE ULTRA BLOOD GAS CONTROLS

K-Number: K952477 · 1995-07-06

ApplicantNova Biomedical Corp.
Decision Date1995-07-06
Product CodeJJS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

STAT PROFILE ULTRA BLOOD GAS CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Nova Biomedical Corp.. It received FDA 510(k) clearance on 1995-07-06 under 510(k) number K952477. The device is classified under product code JJS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STAT PROFILE ULTRA BLOOD GAS CONTROLS?

STAT PROFILE ULTRA BLOOD GAS CONTROLS is a medical device that received FDA 510(k) clearance on 1995-07-06. The listed applicant is Nova Biomedical Corp.. The 510(k) number is K952477.

When did STAT PROFILE ULTRA BLOOD GAS CONTROLS receive FDA 510(k) clearance?

STAT PROFILE ULTRA BLOOD GAS CONTROLS received FDA 510(k) clearance on 1995-07-06, under 510(k) number K952477.

Who is the listed applicant for STAT PROFILE ULTRA BLOOD GAS CONTROLS?

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

What is the FDA product code for STAT PROFILE ULTRA BLOOD GAS CONTROLS?

The FDA product code for STAT PROFILE ULTRA BLOOD GAS CONTROLS is JJS.

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Other records listing Nova Biomedical Corp. 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.

K100602NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPSK101633NOVA MAX PLUS GLOCOSE AND B-KETONE CONTROL SOLUTION-MID, HIGHK091547NOVA MAX PLUS BLOOD GLUCOSE AND B-KETONE MONITOR SYSTEM, NOVA MAX PLUS B-KETONE CONTROL SOLUTIONS, NOVA MAX BLOOD GLUCOSK070960NOVA STATSTRIP XPRESS GLUCOSE HOSPITAL METER SYSTEMK070255NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM, 90001,90002K070068NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPS

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Related Devices (Code: JJS)

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.

K152553CueSee HypoxicEurotrol B.V.K130415HIGH METABOLITE QUALICHECKRadiometer Medical ApsK130236RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3Radiometer Medical ApsK033063MISSION CONTROLSDiamond Diagnostics, Inc.K022525LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (RADIOMETER 700 SERIES) LEVELS, 1,2 AND 3, MODEL 507, 508, 509Bio-RadK022529LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL SYNTHESIS SERIES) LEVELS 1,2, AND 3, MODELS 667,668,669Bio-Rad

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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