510(k) K991371

Device: CARESIDE AMMONIA
Applicant: CARESIDE, INC.
510(k) number: K991371
Product code: JID
Decision: Substantially Equivalent (SESE)
Decision date: 1999-08-03
Date received: 1999-04-20
Regulation: 862.1065
Classification name: Photometric Method, Ammonia
Medical specialty: Clinical Chemistry
Review panel: Clinical Chemistry
Device class: 1
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: KENNETH B ASSARCH, PHARM
Address: 6100 Bristol Pkwy. Culver City CA US 90230 90230

FDA Registration Numbers#

3012963943
3021841051
3002642396
2250051
1319809
1319808
3000308930
1319681

Source Documents#

Other 510(k) Records For Product Code JID #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K820723	KODAK EKTACHEM CLINICAL CHEM. NH3	Eastman Kodak Company	1982-04-01
K813366	AMMONIA TEST	Wako Pure Chemical Industries, Ltd.	1981-12-22

Legacy Summary#

summary

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases