FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

112 results for "Hardy Diagnostics"
97–112 of 112
Search insights Median review: 57d Cleared: 100% Top manufacturer: Hardy Diagnostics Lead specialty: Microbiology
Cleared Jun 17, 1996
COLISCREEN
K961191 · JTO
Hardy Diagnostics
Microbiology · 83d
Cleared Apr 18, 1996
M. CAT BUTYRATE DISK
K960996 · JTO
Hardy Diagnostics
Microbiology · 37d
Cleared Oct 16, 1995
CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST
K951754 · JSO
Hardy Diagnostics
Microbiology · 182d
Cleared May 17, 1994
PARAKIT
K941110 · LKS
Hardy Diagnostics
Microbiology · 71d
Cleared Dec 21, 1993
THAYER MARTIN, MODIFIED PILL POCKET
K934331 · JTY
Hardy Diagnostics
Microbiology · 109d
Cleared Dec 17, 1993
TRANSGROW
K934330 · JTY
Hardy Diagnostics
Microbiology · 105d
Cleared Dec 15, 1993
PYR TEST KIT
K931865 · JTO
Hardy Diagnostics
Microbiology · 245d
Cleared Dec 15, 1993
MARTIN LEWIS WITH LINOCMYCIN
K931864 · JTY
Hardy Diagnostics
Microbiology · 245d
Cleared Jun 15, 1993
NINHYDRIN REAGENT
K931862 · JTO
Hardy Diagnostics
Microbiology · 62d
Cleared May 12, 1993
CATALASE REAGENT
K931414 · JTO
Hardy Diagnostics
Microbiology · 90d
Cleared May 12, 1993
OXYSTRIP
K930693 · JTO
Hardy Diagnostics
Microbiology · 91d
Cleared May 11, 1993
BILE SPOT REAGENT
K931530 · JTN
Hardy Diagnostics
Microbiology · 89d
Cleared May 11, 1993
FERRIC CHLORID REAGENT, 10%
K931413 · JTO
Hardy Diagnostics
Microbiology · 89d
Cleared Apr 23, 1993
VOGUES-PROSKAUER REAGENT A & B
K930720 · JTO
Hardy Diagnostics
Microbiology · 71d
Cleared Apr 23, 1993
INDOLE SPOT & INDOLE KOVACS REAGENT
K930718 · JTO
Hardy Diagnostics
Microbiology · 71d
Cleared Apr 23, 1993
NITRATE REAGENTS A, B AND C
K930717 · JTO
Hardy Diagnostics
Microbiology · 71d