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FDA 510(k)

CALCIUM (ARSENAZO III) FOR MANUAL/AUTO APPLICATION

K-Number: K894476 · 1989-10-12

ApplicantCatachem, Inc.
Decision Date1989-10-12
Product CodeCJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CALCIUM (ARSENAZO III) FOR MANUAL/AUTO APPLICATION is the device name listed in this FDA 510(k) record. The listed applicant is Catachem, Inc.. It received FDA 510(k) clearance on 1989-10-12 under 510(k) number K894476. 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 CALCIUM (ARSENAZO III) FOR MANUAL/AUTO APPLICATION?

CALCIUM (ARSENAZO III) FOR MANUAL/AUTO APPLICATION is a medical device that received FDA 510(k) clearance on 1989-10-12. The listed applicant is Catachem, Inc.. The 510(k) number is K894476.

When did CALCIUM (ARSENAZO III) FOR MANUAL/AUTO APPLICATION receive FDA 510(k) clearance?

CALCIUM (ARSENAZO III) FOR MANUAL/AUTO APPLICATION received FDA 510(k) clearance on 1989-10-12, under 510(k) number K894476.

Who is the listed applicant for CALCIUM (ARSENAZO III) FOR MANUAL/AUTO APPLICATION?

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

What is the FDA product code for CALCIUM (ARSENAZO III) FOR MANUAL/AUTO APPLICATION?

The FDA product code for CALCIUM (ARSENAZO III) FOR MANUAL/AUTO APPLICATION is CJY.

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Other records listing Catachem, 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.

K062503CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KITK945408340-CHLORIDE FOR DISCRETE RANDOM ACCESS ANALYZERK932871UIBC FOR DISCREET RANDOM ACCESS ANALYZERK903341MAGNESIUMK902326AMYLASE FOR MANUAL/AUTOMATED APPLICATIONSK902877TOTAL IRON FOR MANUAL/AUTOMATED

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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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