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FDA 510(k)

ULTRACHEM CA, ITEM #64975

K-Number: K813040 · 1981-11-10

ApplicantHarleco
Decision Date1981-11-10
Product CodeCJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ULTRACHEM CA, ITEM #64975 is the device name listed in this FDA 510(k) record. The listed applicant is Harleco. It received FDA 510(k) clearance on 1981-11-10 under 510(k) number K813040. 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 ULTRACHEM CA, ITEM #64975?

ULTRACHEM CA, ITEM #64975 is a medical device that received FDA 510(k) clearance on 1981-11-10. The listed applicant is Harleco. The 510(k) number is K813040.

When did ULTRACHEM CA, ITEM #64975 receive FDA 510(k) clearance?

ULTRACHEM CA, ITEM #64975 received FDA 510(k) clearance on 1981-11-10, under 510(k) number K813040.

Who is the listed applicant for ULTRACHEM CA, ITEM #64975?

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 ULTRACHEM CA, ITEM #64975?

The FDA product code for ULTRACHEM CA, ITEM #64975 is CJY.

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Other records listing Harleco 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.

K820233ULTRAZYME PLUS GAMMA GT(65055-65056)K813427ULTRACHEM GLUC-DHK813044ULTRACHEM ALB, ITEM #64970K813042ULTRACHEM GLUC-DH SET, ITEM #65048K813038ULTRACHEM TP, ITEM #64974K813041ULTRAZYME-GT, ITEM #64959 & 65032

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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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