Medical Device Manufacturer · US , Clackamas , OR

Alpkem Corp. - FDA 510(k) Cleared Devices

33 submissions · 33 cleared · Since 1985

Recent clearances: TOTAL GALACTOSE, PHENYLALANINE (NINHYDRIN REACTION), TOTAL CHOLESTEROL REAGENT

33

Total

33

Cleared

0

Denied

FDA 510(k) Regulatory Record - Alpkem Corp. Chemistry ✕

33 devices

1-12 of 33

Cleared Jan 11, 1990

TOTAL GALACTOSE

Chemistry · 219d

Cleared Oct 27, 1989

PHENYLALANINE (NINHYDRIN REACTION)

Chemistry · 240d

Cleared May 03, 1989

TOTAL CHOLESTEROL REAGENT

Chemistry · 100d

Cleared Mar 09, 1989

TRIGLYCERIDES - GPO REAGENT

Chemistry · 45d

Cleared Feb 27, 1989

GLUCOSE (GOD) REAGENT

Chemistry · 35d

Cleared Feb 17, 1989

RFA/2 RAPID FLOW ANALYZER W/COMPUTER

Chemistry · 25d

Cleared Feb 17, 1989

ALBUMIN REAGENT

Chemistry · 25d

Cleared Feb 17, 1989

SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU.

Chemistry · 25d

Cleared Sep 02, 1988

RFA-300 RAPID FLOW ANALYZER W/COMPUTER

Chemistry · 45d

Cleared Apr 11, 1986

MAGNESIUM (SUBSTRATE, ENZYME, REAGENT)

Chemistry · 67d

Cleared Jun 25, 1985

INTERNAL STANDARD SOLUTION, EXTERNAL STANDARD SOLU

Chemistry · 49d

Cleared Jun 25, 1985

CA BUFFER CA DYE

Chemistry · 49d