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Ammonia (nh3)

FDA UDIFDA 510(k)

Class I (US FDA UDI)

510(k) K030873

by Randox Laboratories, Ltd.

Identity

Trade Name
AMMONIA (NH3) FDA UDI
Generic Name
Ammonia IVD, kit, enzyme spectrophotometry FDA UDI
Model / Reference
AM1015 FDA UDI

Identifiers

Catalog Number
AM1015 FDA UDI
Primary DI / UDI-DI
05055273200256 FDA UDI
510(k) Number
K030873 FDA UDI
FDA Product Code
JIF FDA UDI
GMDN Term
Ammonia IVD, kit, enzyme spectrophotometry FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1065 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Ammonia IVD, kit, enzyme spectrophotometry

Ammonia (nh3) by Randox Laboratories, Ltd. — Class I — FDA_510K — listed in FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

Similar devices

Also classified as Ammonia IVD, kit, enzyme spectrophotometry.

Cleared under the same submission

K030873 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Randox Laboratories, Ltd.

Sources (2)

  • FDA UDI bd384fa1-40f5-463e-b69f-0fe708e669e4 58 fields · synced Jun 18, 2026
  • FDA 510(k) K030873 1 fields · synced Jun 4, 2026