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FDA 510(k)

KING SODIUM/POTASSIUM STANDARD MODIFIED

K-Number: K931834 · 1993-08-25

ApplicantKing Diagnostics, Inc.
Decision Date1993-08-25
Product CodeJIS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

KING SODIUM/POTASSIUM STANDARD MODIFIED is the device name listed in this FDA 510(k) record. The listed applicant is King Diagnostics, Inc.. It received FDA 510(k) clearance on 1993-08-25 under 510(k) number K931834. The device is classified under product code JIS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KING SODIUM/POTASSIUM STANDARD MODIFIED?

KING SODIUM/POTASSIUM STANDARD MODIFIED is a medical device that received FDA 510(k) clearance on 1993-08-25. The listed applicant is King Diagnostics, Inc.. The 510(k) number is K931834.

When did KING SODIUM/POTASSIUM STANDARD MODIFIED receive FDA 510(k) clearance?

KING SODIUM/POTASSIUM STANDARD MODIFIED received FDA 510(k) clearance on 1993-08-25, under 510(k) number K931834.

Who is the listed applicant for KING SODIUM/POTASSIUM STANDARD MODIFIED?

The FDA 510(k) record lists King Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KING SODIUM/POTASSIUM STANDARD MODIFIED?

The FDA product code for KING SODIUM/POTASSIUM STANDARD MODIFIED is JIS.

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Other records listing King Diagnostics, Inc. 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.

K933329KING DIAGNOSTICS IRON AND TOTAL IRON BINDING CAPACITY REAGENTK931773HDL PRECIPITATING REAGENT (DEXTRAN SULFATE)K931326KING DIAGNOSTICS CK REAGENTK923129KING DIAGNOSTICS GLUCOSE (HK) REAGENTK922969KING DIAGNOSTICS UREA NITROGEN REAGENTK922921KING DIAGNOSTICS CHLORIDE REAGENT

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Related Devices (Code: JIS)

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.

K122126DIRECT LDL/HDL CHOLESTEROL CALIBRATORRandox Laboratories LimitedK061251DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATORDade Behring, Inc.K060266DIMENSION IRON CALIBRATORDade Behring, Inc.K053104DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATORDade Behring, Inc.K032697DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)Dade Behring, Inc.K032608GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETERGonotec Gesellschaft Fuer Mess-Und Regeltechnik MB

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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