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FDA 510(k)

PH BLOOD GAS CONTROL PRODUCTS

K-Number: K884266 · 1989-05-16

ApplicantAlko Diagnostic Corp.
Decision Date1989-05-16
Product CodeJPK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PH BLOOD GAS CONTROL PRODUCTS 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 1989-05-16 under 510(k) number K884266. The device is classified under product code JPK. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PH BLOOD GAS CONTROL PRODUCTS?

PH BLOOD GAS CONTROL PRODUCTS is a medical device that received FDA 510(k) clearance on 1989-05-16. The listed applicant is Alko Diagnostic Corp.. The 510(k) number is K884266.

When did PH BLOOD GAS CONTROL PRODUCTS receive FDA 510(k) clearance?

PH BLOOD GAS CONTROL PRODUCTS received FDA 510(k) clearance on 1989-05-16, under 510(k) number K884266.

Who is the listed applicant for PH BLOOD GAS CONTROL PRODUCTS?

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 PH BLOOD GAS CONTROL PRODUCTS?

The FDA product code for PH BLOOD GAS CONTROL PRODUCTS is JPK.

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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: JPK)

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.

K160586XN-L CHECKStreckK160590XN CHECKStreckK160588XN CHECK BFStreckK160606BC-5D Hematology ControlR&D Systems, Inc.K130962R&D 5D RETIC HEMATOLOGY CONTROLR&D Systems, Inc.K120744XN CHECK BFStreck

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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