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Company · CA

International Newtech Development, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 1995 to 2000. Name variants (Inc, Corp, punctuation) are merged.

8510(k) clearances (0 in 12 months)

0recalls (0 in 12 months)

0recalls that name a 510(k)

Product codes

Code	Device	Records
JHI	Visual, Pregnancy Hcg, Prescription Use	5
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	1
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	1
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	1

Latest 510(k) clearances

Decided	510(k)	Device and applicant	Code
Jan 3, 2000	K993850	URINALYSIS REAGENT STRIPS (10 PARAMETERS) International Newtech Development, Inc., CA	JMT
Apr 9, 1998	K974060	MINISTRIP/ SERUM AND URINE COMBO HCG TEST International Newtech Development, Inc., CA	JHI
Apr 9, 1998	K974059	ONE STEP MIDSTREAM HCG PREGNANCY TEST International Newtech Development, Inc., CA	LCX
Mar 13, 1998	K974009	PS-UNIT CASSETTE/SERUM AND URINE COMBO HCG International Newtech Development, Inc., CA	JHI
Feb 6, 1997	K970176	HCG CONTROLS International Newtech Development, Inc., CA	JJX
Nov 18, 1996	K963133	PS-UNIT CASSETTE/SERUM HCG International Newtech Development, Inc., CA	JHI
Nov 18, 1996	K963132	MINI STRIP/SERUM HCG International Newtech Development, Inc., CA	JHI
Oct 3, 1995	K951705	MINISTRIP HCG International Newtech Development, Inc., CA	JHI

Latest recalls

Date	Firm and product	Code	Linked 510(k)
No recalls in this window.

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