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FDA 510(k)

EKTACHEM CLINICAL CHEMISTRY CALCIUM (CA) SLIDE

K-Number: K961226 · 1996-05-07

ApplicantJohnson & Johnson Clinical Diagnostics, Inc.
Decision Date1996-05-07
Product CodeCJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EKTACHEM CLINICAL CHEMISTRY CALCIUM (CA) SLIDE is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Clinical Diagnostics, Inc.. It received FDA 510(k) clearance on 1996-05-07 under 510(k) number K961226. 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 EKTACHEM CLINICAL CHEMISTRY CALCIUM (CA) SLIDE?

EKTACHEM CLINICAL CHEMISTRY CALCIUM (CA) SLIDE is a medical device that received FDA 510(k) clearance on 1996-05-07. The listed applicant is Johnson & Johnson Clinical Diagnostics, Inc.. The 510(k) number is K961226.

When did EKTACHEM CLINICAL CHEMISTRY CALCIUM (CA) SLIDE receive FDA 510(k) clearance?

EKTACHEM CLINICAL CHEMISTRY CALCIUM (CA) SLIDE received FDA 510(k) clearance on 1996-05-07, under 510(k) number K961226.

Who is the listed applicant for EKTACHEM CLINICAL CHEMISTRY CALCIUM (CA) SLIDE?

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

What is the FDA product code for EKTACHEM CLINICAL CHEMISTRY CALCIUM (CA) SLIDE?

The FDA product code for EKTACHEM CLINICAL CHEMISTRY CALCIUM (CA) SLIDE is CJY.

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Other records listing Johnson & Johnson Clinical Diagnostics, 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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