Medical Device Manufacturer · US , Mchenry , IL

Hillcrest Biologicals - FDA 510(k) Cleared Devices

33 submissions · 33 cleared · Since 1983

Recent clearances: ARBOVIRUS IGG IFA TEST, ARBOVIRUS IGM IFA TEST, Q FEVER IGG IFA TEST

33

Total

33

Cleared

0

Denied

FDA 510(k) Regulatory Record - Hillcrest Biologicals Microbiology ✕

32 devices

1-12 of 32

Cleared Dec 03, 1992

ARBOVIRUS IGG IFA TEST

Microbiology · 478d

Cleared Dec 03, 1992

ARBOVIRUS IGM IFA TEST

Microbiology · 478d

Cleared Oct 21, 1992

Q FEVER IGG IFA TEST

Microbiology · 418d

Cleared Oct 21, 1992

Q FEVER IGM IFA TEST

Microbiology · 154d

Cleared Jun 28, 1991

LYME DISEASE IGM ELISA

Microbiology · 528d

Cleared Jan 16, 1990

EBV VCA ANTIBODY (IGM)

Microbiology · 56d

Cleared Apr 12, 1989

EBV EARLY ANTIGEN (R+D)

Microbiology · 145d

Cleared Mar 15, 1989

LYME DISEASE IFA (IGM)

Microbiology · 190d

Cleared Jan 24, 1989

EBV-VCA ANTIBODY (IGG)

Microbiology · 82d

Cleared Dec 13, 1988

LYME DISEASE IFA (IGG)

Microbiology · 119d

Cleared May 23, 1988

Microbiology · 158d

Cleared Apr 26, 1988

LYME DISEASE ELISA

Microbiology · 82d