Vitros Chemistry Products Calibrator Kit 28, Ref 680 2323 +1 more model

FDA 510(k)

Class I (US FDA 510(k))

510(k) K052645

Identifiers

510(k) Number: K052645 FDA 510(k)
FDA Product Code: GTQ FDA 510(k)
Models / Variants: Vitros Chemistry Products Calibrator Kit 28, Ref 680 2323 FDA 510(k)
Vitros Chemistry Products Fs Calibrator 1, Ref 6801873 FDA 510(k)

Classification

Device Class: Class I FDA 510(k)
Legislation / Framework: 21 CFR Part 866.3720 FDA 510(k)
Regulation Number: 866.3720 FDA 510(k)
Advisory Committee: Microbiology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

Vitros Chemistry Products Calibrator Kit 28, Ref 680 2323 +1 more model by Ortho-Clinical Diagnostics — Class I — FDA_510K — listed in FDA 510(k) — 2 models

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K052645	Class I	Active

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Manufacturer

Manufacturer: Ortho-Clinical Diagnostics

Sources (1)

FDA 510(k) K052645 24 fields · synced Jun 18, 2026