Medical Device Manufacturer · CA , Ontario, L7l 6b8

Biopool AB - FDA 510(k) Cleared Devices

13 submissions · 12 cleared · Since 1990

Total

Cleared

Denied

Biopool AB has 12 FDA 510(k) cleared hematology devices. Based in Ontario, L7l 6b8, CA.

Historical record: 12 cleared submissions from 1990 to 1995.

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

Biopool AB is one of 208 FDA 510(k) medical device manufacturers from Canada in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Biopool AB

13 devices

1-12 of 13

Cleared Sep 25, 1995

SPECTROLYSE ANTIPLASMIN KIT

K941752 · GGP

Hematology · 535d

Cleared Jul 13, 1995

BIOPOOL VWF ELD KIT AND VWF ELD BULK PLATES

SPECTROLYSE HEPARIN KIT

MINUTEX D-DIMER LATEX TEST

K920668 · GHH

Hematology · 246d

Cleared Oct 09, 1992

SPECTROLYSE/PL PAI KIT

K922782 · GGP

Hematology · 122d

Cleared Jan 06, 1992

PROTEIN S EID KIT AND PROTEIN S EID BULK PLATES

K915163 · GGP

Hematology · 53d

Cleared Dec 09, 1991

SPECTROLYSE PROTEIN C KIT

K914307 · GGP

Hematology · 75d

Cleared Aug 22, 1991

SPECTROLYSE PLASMINOGEN SK KIT

SPECTROLYSE ATIII KIT

K902530 · JBQ

Hematology · 65d

Biopool AB - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Biopool AB

Filters