Medical Device Manufacturer · US , Mchenry , IL

E-Y Laboratories, Inc. - FDA 510(k) Cleared Devices

13 submissions · 13 cleared · Since 1983

13

Total

13

Cleared

0

Denied

FDA 510(k) Regulatory Record - E-Y Laboratories, Inc. Microbiology ✕

13 devices

1-12 of 13

Cleared Sep 14, 1994

SWABZYME OXIDASE

Microbiology · 394d

Cleared Sep 09, 1994

GONOCHEK-II, MODIFICATION

Microbiology · 393d

Cleared Sep 09, 1994

B-LACTAMASE REAGENT TUBES

Microbiology · 240d

Cleared Sep 09, 1994

GONOCHEK II REAGENT TUBES

Microbiology · 240d

Cleared Aug 26, 1994

Microbiology · 379d

Cleared Aug 26, 1994

STREP-A-CHEK(TM) REAGENT STRIPS

Microbiology · 235d

Cleared Aug 26, 1994

EY-20 REAGENT TUBES

Microbiology · 228d

Cleared Dec 13, 1984

E-COLI-CHEK TUBE

Microbiology · 38d

Cleared Jul 11, 1984

Microbiology · 8d

Cleared Apr 04, 1984

SWABZYME-OXIDASE

Microbiology · 61d

Cleared Mar 23, 1984

STREP-A-CHEK TUBE

Microbiology · 25d

Cleared Nov 14, 1983

Microbiology · 56d