Medical Device Manufacturer · US , Mchenry , IL

Eastman Kodak Company - FDA 510(k) Cleared Devices

238 submissions · 238 cleared · Since 1977

Recent clearances: KODAK DIRECTVIEW DR 3000 SYSTEM 64KW/80KW GENERATORS, MODELS 6551345, 6551386, KODAK ECLIPSE IMAGE PROCESSING SOFTWARE, KODAK MODEL CR-7400 DIGITAL RADIOGRAPHY SYSTEM

Official Website

238

Total

238

Cleared

0

Denied

FDA 510(k) Regulatory Record - Eastman Kodak Company Microbiology ✕

8 devices

1-8 of 8

Cleared Jan 18, 1991

KODAK SURECELL(TM) STREP A CONTROL FLUID SET

Microbiology · 101d

Cleared Sep 17, 1990

KODAK SURECELL HERPES (HSV) CONTROL FLUID SET

Microbiology · 27d

Cleared Jun 20, 1990

KODAK SURECELL(TM) CHLAMYDIA CONTROL FLUID SET

Microbiology · 51d

Cleared Mar 08, 1990

ADD'L USES FOR THE KODAK SURECELL CHLAMYDIA KIT

Microbiology · 38d

Cleared Jan 02, 1990

KODAK SURECELL CHLAMYDIA TEST KIT (ADD'L USES)

Microbiology · 113d

Cleared Feb 16, 1989

KODAK SURECELL HERPES (HSV) TEST KIT

Microbiology · 99d

Cleared Nov 10, 1988

KODAK SURECELL CHLAMYDIA TEST KIT

Microbiology · 120d

Cleared Apr 21, 1988

KODAK SURECELL STREP A TEST KIT

Microbiology · 15d