Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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