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

491 results for "Roche Diagnostics"
169–192 of 491
Search insights Median review: 77d Cleared: 99% Top manufacturer: Roche Diagnostics Corp. Lead specialty: Chemistry
Cleared Sep 10, 2010
ELECSYS FERRITIN CALCHECK 5
K102267 · JJX
Roche Diagnostics
Chemistry · 32d
Cleared Sep 10, 2010
TINA-QUANT ALBUMIN GEN 2
K101203 · DCF
Roche Diagnostics
Chemistry · 134d
Cleared Sep 09, 2010
COBAS 8000 MODULAR SERIES ANALYZER
K100853 · DCF
Roche Diagnostics Corp.
Chemistry · 167d
Cleared Sep 08, 2010
ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS, ROCHE DIAGNOSTICS...
K101456 · JIX
Roche Diagnostics
Chemistry · 105d
Cleared Sep 01, 2010
PRECICONTROL CLINCHEM MULTI 1 AND 2
K102016 · JJY
Roche Diagnostics
Chemistry · 44d
Cleared Aug 31, 2010
ELECSYS DIGOXIN CALCHECK 5
K102044 · JJX
Roche Diagnostics
Chemistry · 41d
Cleared Aug 27, 2010
ELECSYS PRECICONTROL MULTIMARKER
K102157 · JJY
Roche Diagnostics
Chemistry · 28d
Cleared Aug 27, 2010
ACCU-CHEK ULTRFLEX INFUSION SET
K101196 · FPA
Roche Diagnostics Corp.
General Hospital · 120d
Cleared Jul 28, 2010
AMPHETAMINES II ASSAY
K093664 · DKZ
Roche Diagnostics Corp.
Chemistry · 243d
Cleared Jun 22, 2010
TINA-QUANT FERRITIN GEN. 4
K100538 · DBF
Roche Diagnostics
Immunology · 117d
Cleared Jun 22, 2010
ANTI-HAV IGM
K093955 · LOL
Roche Diagnostics
Microbiology · 181d
Cleared Jun 11, 2010
ELECSYS INSULIN CALCHECK 5
K101075 · JJX
Roche Diagnostics Corp.
Chemistry · 53d
Cleared Apr 27, 2010
ELECSYS FOLATE III CALCHECK 5
K094031 · JJX
Roche Diagnostics
Chemistry · 118d
Cleared Apr 26, 2010
ELECSYS C-PEPTIDE CALCHECK 5
K100810 · JJX
Roche Diagnostics
Chemistry · 35d
Cleared Apr 23, 2010
ELECSYS TESTOSTERONE II IMMUNOASSAY
K093421 · CDZ
Roche Diagnostics Corp.
Chemistry · 171d
Cleared Apr 15, 2010
ELECSYS TSH CALCHECK 5
K093836 · JJX
Roche Diagnostics
Chemistry · 121d
Cleared Apr 02, 2010
COBAS U411 TEST SYSTEM
K093555 · KQO
Roche Diagnostics
Chemistry · 136d
Cleared Apr 01, 2010
ELECSYS TROPONIN I CALCHECK 5
K100594 · JJX
Roche Diagnostics
Chemistry · 30d
Cleared Mar 29, 2010
ELECSYS CK-MB CALCHECK 5
K093582 · JJX
Roche Diagnostics
Chemistry · 130d
Cleared Mar 19, 2010
ELECSYS TROPONIN T CALCHECK 5
K092848 · JJX
Roche Diagnostics Corp.
Chemistry · 184d
Cleared Mar 18, 2010
COAGUCHEK XS PRO SYSTEM
K093460 · GJS
Roche Diagnostics
Hematology · 132d
Cleared Mar 18, 2010
TINA-QUANT CERULOPLASMIN
K091741 · CHN
Roche Diagnostics
Immunology · 275d
Cleared Mar 12, 2010
ELECSYS RUBELLA IGM IMMUNOASSAY
K092322 · LFX
Roche Diagnostics
Microbiology · 220d
Cleared Mar 05, 2010
COAGUCHEK XS PLUS PST SYSTEM
K092940 · GJS
Roche Diagnostics Corp.
Hematology · 162d