Medical Device Manufacturer · US , Mchenry , IL

Diagnostic Technology, Inc. - FDA 510(k) Cleared Devices

28 submissions · 28 cleared · Since 1979

28

Total

28

Cleared

0

Denied

FDA 510(k) Regulatory Record - Diagnostic Technology, Inc. Microbiology ✕

8 devices

1-8 of 8

Cleared Nov 05, 1991

LYME-CHECK(TM) TEST KIT

Microbiology · 729d

Cleared Oct 16, 1990

EBV/EA-CHECK TM TEST KIT

Microbiology · 68d

Cleared Jun 20, 1989

RESUBMITTED EBV/IGM-CHECK TEST KIT

Microbiology · 132d

Cleared Jun 20, 1989

HSV-CHECK(TM) TEST KIT

Microbiology · 123d

Cleared Jun 20, 1989

EBNA-CHECK(TM) TEST KIT

Microbiology · 95d

Cleared Jun 25, 1987

EBV-CHECK(TM) TEST KIT (IGG)

Microbiology · 79d

Cleared Apr 29, 1987

CHLAMYDIA-CHECK(TM) DIRECT & CULTURE CONFIR. KIT

Microbiology · 190d

Cleared Nov 28, 1986

EBV/VCA-CHECK(TM) ANTIGEN SLIDES

Microbiology · 86d