Medical Device Manufacturer · CA , Richmond, B.C.

International Newtech Development, Inc. - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 1995

Recent clearances: ONE STEP MIDSTREAM HCG PREGNANCY TEST, MINISTRIP/ SERUM AND URINE COMBO HCG TEST, PS-UNIT CASSETTE/SERUM AND URINE COMBO HCG

8

Total

8

Cleared

0

Denied

FDA 510(k) Regulatory Record - International Newtech Development, Inc. Chemistry ✕

8 devices

1-8 of 8

Cleared Jan 03, 2000

URINALYSIS REAGENT STRIPS (10 PARAMETERS)

Chemistry · 52d

Cleared Apr 09, 1998

ONE STEP MIDSTREAM HCG PREGNANCY TEST

Chemistry · 164d

Cleared Apr 09, 1998

MINISTRIP/ SERUM AND URINE COMBO HCG TEST

Chemistry · 164d

Cleared Mar 13, 1998

PS-UNIT CASSETTE/SERUM AND URINE COMBO HCG

Chemistry · 143d

Cleared Feb 06, 1997

Chemistry · 20d

Cleared Nov 18, 1996

MINI STRIP/SERUM HCG

Chemistry · 98d

Cleared Nov 18, 1996

PS-UNIT CASSETTE/SERUM HCG

Chemistry · 98d

Cleared Oct 03, 1995

Chemistry · 172d