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FDA 510(k)

HICHEM GLUCOSE/HK REAGENT KIT

K-Number: K960084 · 1996-04-04

ApplicantHi Chem, Inc.
Decision Date1996-04-04
Product CodeCFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HICHEM GLUCOSE/HK REAGENT KIT 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 1996-04-04 under 510(k) number K960084. The device is classified under product code CFR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HICHEM GLUCOSE/HK REAGENT KIT?

HICHEM GLUCOSE/HK REAGENT KIT is a medical device that received FDA 510(k) clearance on 1996-04-04. The listed applicant is Hi Chem, Inc.. The 510(k) number is K960084.

When did HICHEM GLUCOSE/HK REAGENT KIT receive FDA 510(k) clearance?

HICHEM GLUCOSE/HK REAGENT KIT received FDA 510(k) clearance on 1996-04-04, under 510(k) number K960084.

Who is the listed applicant for HICHEM GLUCOSE/HK REAGENT KIT?

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 GLUCOSE/HK REAGENT KIT?

The FDA product code for HICHEM GLUCOSE/HK REAGENT KIT is CFR.

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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.

K951818HICHEM 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)K862027LDP REAGENT CARTRIDGE (NO. 88216)

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Related Devices (Code: CFR)

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.

K253490Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutionsRoche DiagnosticsK252357Glucose2Abbott IrelandK220134cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSHRoche DiagnosticsK191899Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutionsRoche DiagnosticsK170316ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEMAbbott LaboratoriesK153644ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL IIElitechgroup

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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