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FDA 510(k)

HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808

K-Number: K941764 · 1994-05-13

ApplicantHi Chem, Inc.
Decision Date1994-05-13
Product CodeCJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808 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 1994-05-13 under 510(k) number K941764. 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 FOR THE SYNCHRON CX3 PROD. NO. 88808?

HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808 is a medical device that received FDA 510(k) clearance on 1994-05-13. The listed applicant is Hi Chem, Inc.. The 510(k) number is K941764.

When did HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808 receive FDA 510(k) clearance?

HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808 received FDA 510(k) clearance on 1994-05-13, under 510(k) number K941764.

Who is the listed applicant for HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808?

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 CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808?

The FDA product code for HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808 is CJY.

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Other records listing Hi Chem, Inc. as applicant

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K960084HICHEM GLUCOSE/HK REAGENT KITK951818HICHEM ALT REAGENT KITK943684HICHEM ENZYME VERIFIER KITK902673HI 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: 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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