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Kowa Fm-600

FDA UDI

Class II (US FDA UDI)

by Kowa Co. , Ltd.

Identity

Trade Name
KOWA FM-600 FDA UDI
Generic Name
Aqueous flare/cell measuring system FDA UDI
Device Name
KOWA FM-600 is an instrument to measure the protein level contained in aqueous humor of the anterior chamber of human eye. FDA UDI
Model / Reference
LSS50BK FDA UDI
Description
KOWA FM-600 is an instrument to measure the protein level contained in aqueous humor of the anterior chamber of human eye. FDA UDI

Identifiers

Primary DI / UDI-DI
04987646804024 FDA UDI
510(k) Number
K091039 FDA UDI
FDA Product Code
MYC FDA UDI
GMDN Term
Aqueous flare/cell measuring system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
886.1570 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Height — 458 Millimeter FDA UDI
Depth — 457 Millimeter FDA UDI
Width — 274 Millimeter FDA UDI
Weight — 18 Kilogram FDA UDI

Category: Aqueous flare/cell measuring system

Kowa Fm-600 by Kowa Co. , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Kowa Co. , Ltd.

Sources (1)

  • FDA UDI cb1ee304-13ff-4c43-9105-03c9ade03685 36 fields · synced May 31, 2026