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FDA 510(k)

ROCHE REAGENT FOR CALCIUM

K-Number: K883453 · 1988-10-25

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1988-10-25
Product CodeCJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ROCHE REAGENT FOR CALCIUM is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1988-10-25 under 510(k) number K883453. 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 ROCHE REAGENT FOR CALCIUM?

ROCHE REAGENT FOR CALCIUM is a medical device that received FDA 510(k) clearance on 1988-10-25. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K883453.

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

ROCHE REAGENT FOR CALCIUM received FDA 510(k) clearance on 1988-10-25, under 510(k) number K883453.

Who is the listed applicant for ROCHE REAGENT FOR CALCIUM?

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

What is the FDA product code for ROCHE REAGENT FOR CALCIUM?

The FDA product code for ROCHE REAGENT FOR CALCIUM is CJY.

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Other records listing Roche Diagnostic Systems, Inc. as applicant

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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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