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FDA 510(k)

ALKO TONOMETERED SALINE CONTROL

K-Number: K950902 · 1995-03-30

ApplicantAlko Diagnostic Corp.
Decision Date1995-03-30
Product CodeJJS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALKO TONOMETERED SALINE CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Alko Diagnostic Corp.. It received FDA 510(k) clearance on 1995-03-30 under 510(k) number K950902. 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 ALKO TONOMETERED SALINE CONTROL?

ALKO TONOMETERED SALINE CONTROL is a medical device that received FDA 510(k) clearance on 1995-03-30. The listed applicant is Alko Diagnostic Corp.. The 510(k) number is K950902.

When did ALKO TONOMETERED SALINE CONTROL receive FDA 510(k) clearance?

ALKO TONOMETERED SALINE CONTROL received FDA 510(k) clearance on 1995-03-30, under 510(k) number K950902.

Who is the listed applicant for ALKO TONOMETERED SALINE CONTROL?

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

What is the FDA product code for ALKO TONOMETERED SALINE CONTROL?

The FDA product code for ALKO TONOMETERED SALINE CONTROL is JJS.

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Other records listing Alko Diagnostic 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.

K001484CALIBRATION SOLUTION 1, MODEL A943-837; CALIBRATION SOLUTION 2, MODEL A943-839; RINSE SOLUTION KIT, MODEL A943-838K982501ELECTROLYTE BUFFER A443-325, ELECTROLYTE REFERENCE REAGENT A443-315, CO2 ACID REAGENT A443-330, CO2 ALKALINE BUFFER A44K972004ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMSK970921STANDARD A MULTIPLY (A540-0), STANDARD B MULTIPLY (A550-0), STANDARD C MULTIPLY (A560-0)K962864THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERSK963734ISE REAGENTS FOR HITACHI 700 SERIES AND 911 CLINICAL CHEMISTRY SYSTEMS

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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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