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FDA 510(k)

HICHEM CALCIUM REAGENT KIT

K-Number: K981794 · 1998-07-29

ApplicantHichem Diagnostics
Decision Date1998-07-29
Product CodeCJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HICHEM CALCIUM REAGENT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Hichem Diagnostics. It received FDA 510(k) clearance on 1998-07-29 under 510(k) number K981794. The device is classified under product code CJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HICHEM CALCIUM REAGENT KIT?

HICHEM CALCIUM REAGENT KIT is a medical device that received FDA 510(k) clearance on 1998-07-29. The listed applicant is Hichem Diagnostics. The 510(k) number is K981794.

When did HICHEM CALCIUM REAGENT KIT receive FDA 510(k) clearance?

HICHEM CALCIUM REAGENT KIT received FDA 510(k) clearance on 1998-07-29, under 510(k) number K981794.

Who is the listed applicant for HICHEM CALCIUM REAGENT KIT?

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

What is the FDA product code for HICHEM CALCIUM REAGENT KIT?

The FDA product code for HICHEM CALCIUM REAGENT KIT is CJY.

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Other records listing Hichem Diagnostics 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.

K963383HICHEM ALP/AMP REAGENT KITK953860HICHEM ISE DILUENT KIT 70008K953863HICHEM ISE STANDARDS KIT 70011K953862HICHEM ISEKCI SOLUTION KIT 70010K953861HICHEM ISE INTDERNAL REFERENCE KIT 70009K951751HICHEM AST REAGENT KIT

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Related Devices (Code: CJY)

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.

K244042Calcium2Abbott IrelandK191396Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine JaffeHORIBA ABX SASK182042Randox Calcium (Ca)Randox Laboratories, Ltd.K123171ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONTHORIBA ABX SASK120626EON CALCIUM REGENTVital Diagnostics (Manufacturing) PtyltdK083386ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL), P/N 02189915 (70 ML FILL)Siemens Healthcare Diagnostics

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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