Gen-Probe, Inc. - FDA 510(k) Cleared Devices

Cleared Nov 13, 1990

ACCUPROBE MYCOBACTERIUM KANSASII CULT CONFIRM TEST

K904463 · LQF

Microbiology · 43d

Cleared Oct 02, 1990

ACCUPROBE CRYPTOCOCCUS NEOFORMANS CULTURE TEST

K903556 · MDE

Microbiology · 56d

Cleared Oct 02, 1990

ACCUPROBE COCCIDIOIDES IMMITIS CULTURE CONFIRM.

K904047 · MDF

Microbiology · 28d

Cleared Sep 12, 1990

ACCUPROBE BLASTOMYCES DERMATIT CULT CONFIRM TEST

K903201 · MDC

Microbiology · 54d

Cleared Aug 23, 1990

ACCUPROBE MYCOBACTERIUM AVIUM CULTURE TEST

K896494 · LQF

Microbiology · 283d

Cleared Aug 23, 1990

ACCUPROBE MYCOBACTERIUM INTRACELLULARE CULTURE

K897077 · LQF

Microbiology · 244d

Cleared Aug 06, 1990

ACCUPROBE STAPHYLOCOCCUS AUREUS CULTURE CONFIRMA.

K902213 · MCS

Microbiology · 82d

Cleared Aug 06, 1990

ACCUPROBE STREPTOCOCCUS PNEUMONIAE CULTURE CONFIR.

K902908 · MCT

Microbiology · 35d

Cleared Jun 20, 1990

ACCUPROBE LISTERIA MONOCYTOGENES CULTURE CONFIRMA.

K901397 · MCC

Microbiology · 86d

Cleared May 02, 1990

ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTURE

K897078 · LQF

Microbiology · 131d

Cleared Apr 16, 1990

ACCUPROBE MYCOBACTERIUM GORDONAE CULTURE TEST

K896492 · LQF

Microbiology · 154d

Cleared Apr 11, 1990

ACCUPROBE MYCOBACTERIUM TUBERCULOSIS COMPLEX TEST

K896493 · LQF

Microbiology · 149d

Cleared Mar 08, 1990

ACCUPROBE HAEOMPHILUS INFLUENZAE CULTURE

K897079 · MCC

Microbiology · 76d

Cleared Feb 01, 1990

ACCUPROBE HISTOPLASMA CAPSULATUM CULTURE CONF.TEST

K896859 · MBT

Microbiology · 58d

Cleared Nov 29, 1989

ACCUPROBE ENTEROCOCCUS CULTURE CONFIRMATION

K895103 · GTZ

Microbiology · 106d

Cleared Nov 14, 1989

ACCUPROBE GROUP B STREPTOCOCCUS CULTURE CONFIRMA.

K894711 · GTZ

Microbiology · 111d

Cleared Nov 14, 1989

ACCUPROBE CAMPYLOBACTER CULTURE CONFIRMATION

K894712 · LQO

Microbiology · 111d

Cleared Nov 14, 1989

ACCUPROBE NEISSERIA GONORRHOEAE CULTURE CONFIRMA.

K895583 · LSL

Microbiology · 60d

Cleared Sep 15, 1989

GEN-PROBE PACE SYSTEM URINE SCREEN

K892216 · JXA

Microbiology · 165d

Cleared Mar 13, 1989

RAPID DIAG. SYSTEM FOR MYCOBACTERIUM GORDONAE

K890089 · LQF

Microbiology · 62d

Cleared Apr 25, 1988

PACE SYSTEM FOR NEISSERIA GONORRHOEAE ADDI. CLAIMS

K881277 · LSL

Microbiology · 38d

Cleared Mar 01, 1988

GEN-PROBE PACE SYSTEM FOR NEISSERIA GONORRHOEAE

K874620 · LSL

Microbiology · 113d

Cleared Dec 29, 1987

GEN-PROBE(R) PACE(TM) SYSTEM CHLAMYDIA TRACHOMATIS

K874878 · LSK

Microbiology · 29d

Cleared Oct 28, 1987

RAPID DIAGNOSTIC SYSTEM FOR CHLAMYDIA TRACHOMATIS

K871878 · LSK

Microbiology · 167d

Cleared Jul 30, 1987

RAPID DIAGNOSTIC SYSTEM FOR MYCOBACTERIUM TUBER.

K871795 · LQF

Microbiology · 84d