Optical Qc Filters

FDA UDI

Class I (US FDA UDI)

by Instrumentation Laboratory Company

Identity

Trade Name: OPTICAL QC FILTERS FDA UDI
Generic Name: Co-oximetry analyser IVD, point-of-care FDA UDI
Device Name: OPTICAL QC FILTERS FDA UDI
Model / Reference: 06320480221 FDA UDI
Description: OPTICAL QC FILTERS FDA UDI

Identifiers

Catalog Number: 06320480221 FDA UDI
Primary DI / UDI-DI: 08426950813590 FDA UDI
510(k) Number: K951485 FDA UDI
FDA Product Code: JKS FDA UDI
GMDN Term: Co-oximetry analyser IVD, point-of-care FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.3220 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Co-oximetry analyser IVD, point-of-care

Optical Qc Filters by Instrumentation Laboratory Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K951485 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Instrumentation Laboratory Company

Sources (1)

FDA UDI edf29155-bf84-4503-abcf-4ba4745952ef 37 fields · synced Jun 1, 2026