Medical Device Manufacturer · FI , 20101 Turku

Orion Corp. - FDA 510(k) Cleared Devices

21 submissions · 20 cleared · Since 1985

21

Total

20

Cleared

0

Denied

FDA 510(k) Regulatory Record - Orion Corp. Microbiology ✕

12 devices

1-12 of 12

Cleared May 04, 1992

RUBALEX, MODIFICATION

Microbiology · 346d

Cleared Apr 26, 1990

RESUBMITTED MODIFIED RUBALEX

Microbiology · 17d

Cleared Mar 02, 1989

DENTOCULT SM-STRIP MUTANS

Microbiology · 43d

Cleared Sep 22, 1987

MODIFIED CHLAMYSET ANTIGEN

Microbiology · 74d

Cleared Sep 11, 1987

CHLAMYSET ANTIBODY EIA

Microbiology · 303d

Cleared Sep 11, 1987

DENTOCULT-SM CULTURE-PADDLE

Microbiology · 88d

Cleared Jun 10, 1987

ORICULT-N CULTURE-PADDLE

Microbiology · 13d

Cleared Jun 04, 1986

RUBALEX (REVISED VERSION)

Microbiology · 27d

Cleared Apr 28, 1986

CHLAMYSET ANTIGEN

Microbiology · 259d

Cleared Mar 12, 1986

Microbiology · 254d

Cleared Mar 04, 1986

Microbiology · 21d

Cleared Oct 29, 1985

DENTOCULT CULTURE-PADDLE

Microbiology · 221d