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"
385–408 of 491
Search insights Median review: 77d Cleared: 99% Top manufacturer: Roche Diagnostics Corp. Lead specialty: Chemistry
Cleared Mar 21, 2002
DIABETES ASSISTANT SOFTWARE
K014139 · CGA
Roche Diagnostics Corp.
Chemistry · 94d
Cleared Mar 06, 2002
ELECSYS ANTI-TG CALCHECK
K020369 · JJX
Roche Diagnostics Corp.
Immunology · 30d
Cleared Jan 08, 2002
ROCHE ACETAMINOPHEN
K013757 · LDP
Roche Diagnostics Corp.
Toxicology · 56d
Cleared Dec 21, 2001
ABUSCREEN ONLINE OPIATES 300 / 2000
K013482 · DJG
Roche Diagnostics Corp.
Toxicology · 63d
Cleared Dec 05, 2001
ACCU-CHEK ACTIVE TEST SYSTEM
K012324 · NBW
Roche Diagnostics Corp.
Chemistry · 135d
Cleared Nov 30, 2001
INFLUENZA A/B RAPID TEST, CAT NO 2158 663
K011684 · PSZ
Roche Diagnostics Corp.
Microbiology · 184d
Cleared Nov 29, 2001
TINA-QUANT COMPLEMENT C3C TEST SYSTEM
K012361 · CZW
Roche Diagnostics Corp.
Immunology · 127d
Cleared Nov 29, 2001
TINA-QUANT COMPLEMENT C4 TEST SYSTEM
K012359 · DBI
Roche Diagnostics Corp.
Immunology · 127d
Cleared Nov 16, 2001
TINA-QUANT APOLIPOPROTEIN VER.2
K013249 · DER
Roche Diagnostics Corp.
Chemistry · 49d
Cleared Nov 16, 2001
TINA-QUANT APOLIPOPROTEIN B VER.2
K013206 · DFC
Roche Diagnostics Corp.
Chemistry · 52d
Cleared Nov 15, 2001
TINA-QUANT APOLIPOPROTEIN A-1 VER.2
K013278 · DEL
Roche Diagnostics Corp.
Chemistry · 45d
Cleared Nov 13, 2001
TINA-QUANT APOLIPOPROTEIN B VER.2
K013207 · DFC
Roche Diagnostics Corp.
Chemistry · 49d
Cleared Nov 05, 2001
ONTRAK TESTCARD 9
K012396 · DKZ
Roche Diagnostics Corp.
Toxicology · 101d
Cleared Nov 02, 2001
OMNI C ANALYZER
K013373 · CEM
Roche Diagnostics Corp.
Chemistry · 22d
Cleared Sep 26, 2001
URISYS 2400 URINE TEST STRIP
K012397 · JIL
Roche Diagnostics Corp.
Chemistry · 61d
Cleared Sep 19, 2001
TINA-QUANT TRANSFERRIN VER.2
K012393 · DDG
Roche Diagnostics Corp.
Immunology · 54d
Cleared Sep 19, 2001
TINA-QUANT TRANSFERRIN VER.2
K012371 · DDG
Roche Diagnostics Corp.
Immunology · 55d
Cleared Aug 24, 2001
MODIFICATION TO ELECSYS FSH II CALSET
K012399 · JIT
Roche Diagnostics Corp.
Chemistry · 28d
Cleared Aug 09, 2001
MODIFICATION TO ACCU-CHEK INFORM METER
K012210 · NBW
Roche Diagnostics Corp.
Chemistry · 24d
Cleared Aug 08, 2001
MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION
K012286 · LBS
Roche Diagnostics Corp.
Chemistry · 19d
Cleared Aug 07, 2001
MODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND GENERATION
K012287 · MRR
Roche Diagnostics Corp.
Chemistry · 18d
Cleared Jun 25, 2001
CALIBRATOR FOR AUTOMATED SYSTEMS
K011226 · JIX
Roche Diagnostics Corp.
Chemistry · 66d
Cleared Jun 25, 2001
MODIFICATION TO REFLOTRON AMYLASE, CAT. 1200658
K011145 · JFJ
Roche Diagnostics Corp.
Chemistry · 91d
Cleared Jun 20, 2001
ACCU-CHEK ACTIVE SYSTEM
K011738 · NBW
Roche Diagnostics Corp.
Chemistry · 15d