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FDA 510(k)

FLUIDS PACK

K-Number: K944516 · 1994-11-02

ApplicantAlko Diagnostic Corp.
Decision Date1994-11-02
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FLUIDS PACK 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 1994-11-02 under 510(k) number K944516. The device is classified under product code JIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLUIDS PACK?

FLUIDS PACK is a medical device that received FDA 510(k) clearance on 1994-11-02. The listed applicant is Alko Diagnostic Corp.. The 510(k) number is K944516.

When did FLUIDS PACK receive FDA 510(k) clearance?

FLUIDS PACK received FDA 510(k) clearance on 1994-11-02, under 510(k) number K944516.

Who is the listed applicant for FLUIDS PACK?

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 FLUIDS PACK?

The FDA product code for FLUIDS PACK is JIT.

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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: JIT)

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.

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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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