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FDA 510(k)

HICHEM ION 2/4 URINE RANGE CALIBRATOR

K-Number: K842450 · 1984-08-16

ApplicantHi Chem, Inc.
Decision Date1984-08-16
Product CodeJIS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HICHEM ION 2/4 URINE RANGE CALIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Hi Chem, Inc.. It received FDA 510(k) clearance on 1984-08-16 under 510(k) number K842450. 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 HICHEM ION 2/4 URINE RANGE CALIBRATOR?

HICHEM ION 2/4 URINE RANGE CALIBRATOR is a medical device that received FDA 510(k) clearance on 1984-08-16. The listed applicant is Hi Chem, Inc.. The 510(k) number is K842450.

When did HICHEM ION 2/4 URINE RANGE CALIBRATOR receive FDA 510(k) clearance?

HICHEM ION 2/4 URINE RANGE CALIBRATOR received FDA 510(k) clearance on 1984-08-16, under 510(k) number K842450.

Who is the listed applicant for HICHEM ION 2/4 URINE RANGE CALIBRATOR?

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

What is the FDA product code for HICHEM ION 2/4 URINE RANGE CALIBRATOR?

The FDA product code for HICHEM ION 2/4 URINE RANGE CALIBRATOR is JIS.

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Other records listing Hi Chem, 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.

K960084HICHEM GLUCOSE/HK REAGENT KITK951818HICHEM ALT REAGENT KITK943684HICHEM ENZYME VERIFIER KITK941764HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808K902673HI CHEM TOTAL PROTEIN/ALBUMIN SERUM RANGE LIN STNDK863617ION 2/4 FLOW CELL CLEANER (PRODUCT #88656)

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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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