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FDA 510(k)

COULTER CALCIUM REAGENT

K-Number: K900231 · 1990-04-03

ApplicantCoulter Corp.
Decision Date1990-04-03
Product CodeCJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COULTER CALCIUM REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Coulter Corp.. It received FDA 510(k) clearance on 1990-04-03 under 510(k) number K900231. 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 COULTER CALCIUM REAGENT?

COULTER CALCIUM REAGENT is a medical device that received FDA 510(k) clearance on 1990-04-03. The listed applicant is Coulter Corp.. The 510(k) number is K900231.

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

COULTER CALCIUM REAGENT received FDA 510(k) clearance on 1990-04-03, under 510(k) number K900231.

Who is the listed applicant for COULTER CALCIUM REAGENT?

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

What is the FDA product code for COULTER CALCIUM REAGENT?

The FDA product code for COULTER CALCIUM REAGENT is CJY.

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Other records listing Coulter Corp. 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.

K993356COULTER HEMATOLOGY ANALYZERS WITH IRF & MRV ANALYSESK991070COULTER Z2 ANALYZERK990327RETICONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMSK990172TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS WITH CYTO-STAT TETRACHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 MONOCLAK990352COULTER AC T DIFF 2 ANALYZERK984216IMMUNO-TROL CONTROL CELLS

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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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