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FDA 510(k)

HI CHEM DIAGNOSTICS LDL REAGENT CARTRIDGE

K-Number: K861419 · 1986-04-28

ApplicantHi Chem, Inc.
Decision Date1986-04-28
Product CodeCFJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HI CHEM DIAGNOSTICS LDL REAGENT CARTRIDGE 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 1986-04-28 under 510(k) number K861419. The device is classified under product code CFJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HI CHEM DIAGNOSTICS LDL REAGENT CARTRIDGE?

HI CHEM DIAGNOSTICS LDL REAGENT CARTRIDGE is a medical device that received FDA 510(k) clearance on 1986-04-28. The listed applicant is Hi Chem, Inc.. The 510(k) number is K861419.

When did HI CHEM DIAGNOSTICS LDL REAGENT CARTRIDGE receive FDA 510(k) clearance?

HI CHEM DIAGNOSTICS LDL REAGENT CARTRIDGE received FDA 510(k) clearance on 1986-04-28, under 510(k) number K861419.

Who is the listed applicant for HI CHEM DIAGNOSTICS LDL REAGENT CARTRIDGE?

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 HI CHEM DIAGNOSTICS LDL REAGENT CARTRIDGE?

The FDA product code for HI CHEM DIAGNOSTICS LDL REAGENT CARTRIDGE is CFJ.

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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: CFJ)

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.

K131975ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENTAlfa Wassermann Diagnostic Technologies, Inc.K091544S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017Alfa Wassermann, Inc.K051108PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEMAbaxis, Inc.K974859LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30Diagnostic Chemicals , Ltd.K973589LIQUID LDH-L REAGENT SETPointe Scientific, Inc.,K970684LACTATE DEHYDROGENASE (LD)Randox Laboratories, Ltd.

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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