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FDA 510(k)

CALCIUM SET, ITEM NO. 65004

K-Number: K771928 · 1977-11-14

ApplicantHarleco
Decision Date1977-11-14
Product CodeCJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CALCIUM SET, ITEM NO. 65004 is the device name listed in this FDA 510(k) record. The listed applicant is Harleco. It received FDA 510(k) clearance on 1977-11-14 under 510(k) number K771928. 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 SET, ITEM NO. 65004?

CALCIUM SET, ITEM NO. 65004 is a medical device that received FDA 510(k) clearance on 1977-11-14. The listed applicant is Harleco. The 510(k) number is K771928.

When did CALCIUM SET, ITEM NO. 65004 receive FDA 510(k) clearance?

CALCIUM SET, ITEM NO. 65004 received FDA 510(k) clearance on 1977-11-14, under 510(k) number K771928.

Who is the listed applicant for CALCIUM SET, ITEM NO. 65004?

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

What is the FDA product code for CALCIUM SET, ITEM NO. 65004?

The FDA product code for CALCIUM SET, ITEM NO. 65004 is CJY.

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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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