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

Total

Cleared

Denied

Alpkem Corp. has 33 FDA 510(k) cleared chemistry devices. Based in Clackamas, US.

Historical record: 33 cleared submissions from 1985 to 1990.

Browse the complete list of FDA 510(k) cleared chemistry devices from this manufacturer. Filter by specialty or product code using the sidebar.

Alpkem Corp. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Alpkem Corp.

33 devices

1-12 of 33

PHENYLALANINE (NINHYDRIN REACTION)

K891070 · JNB

Chemistry · 240d

Cleared May 03, 1989

TOTAL CHOLESTEROL REAGENT

K890334 · CHH

Chemistry · 100d

Cleared Mar 09, 1989

TRIGLYCERIDES - GPO REAGENT

K890337 · CDT

Chemistry · 45d

Cleared Feb 27, 1989

GLUCOSE (GOD) REAGENT

K890336 · CGA

Chemistry · 35d

Cleared Feb 17, 1989

RFA/2 RAPID FLOW ANALYZER W/COMPUTER

SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU.

K890335 · CGE

Chemistry · 25d

Cleared Sep 02, 1988

RFA-300 RAPID FLOW ANALYZER W/COMPUTER

K883020 · JJF

Chemistry · 45d

Cleared Apr 11, 1986

MAGNESIUM (SUBSTRATE, ENZYME, REAGENT)

K860367 · JGF

Chemistry · 67d

Cleared Jun 25, 1985

INTERNAL STANDARD SOLUTION, EXTERNAL STANDARD SOLU

Alpkem Corp. - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Alpkem Corp.

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