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

Filters: Immunology ×
3,794 results
1369–1392 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Apr 27, 1998
STRATUS CS MYOGLOBIN (MYO) TESTPAK
K981102 · DDR
Dade Behring, Inc.
Immunology · 32d
Cleared Apr 24, 1998
SERAQUEST ANTI-DSDNA
K980391 · LRM
Quest Intl., Inc.
Immunology · 81d
Cleared Apr 23, 1998
THE COMPLEXED PSA ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
K980376 · LTJ
Bayer Corp.
Immunology · 83d
Cleared Apr 23, 1998
DIAMEDIX IS-ENA-6 SCREEN TEST SYSTEM
K980759 · LLL
Diamedix Corp.
Immunology · 55d
Cleared Apr 21, 1998
IMMULITE 2000 3RD GENERATION PSA
K974842 · LTJ
Diagnostic Products Corp.
Immunology · 118d
Cleared Apr 21, 1998
IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT
K980855 · DHX
Dpc Cirrus
Immunology · 47d
Cleared Apr 15, 1998
BARD BTA TRAK TEST
K971402 · MMW
Bard Diagnostic Sciences,Inc.
Immunology · 365d
Cleared Apr 03, 1998
ADVANTAGE CHEMILUMINESCENCE PROSTATE SPECIFIC ANTIGEN (PSA) IMMUNOASSAY
K980716 · LTJ
Nichols Institute Diagnostics
Immunology · 86d
Cleared Apr 02, 1998
NOVA LITE ENDOMYSIAL
K980312 · DBL
Inova Diagnostics, Inc.
Immunology · 65d
Cleared Mar 25, 1998
ELECSYS CA 125II ON THE ELECSYS 1010
K980240 · LTK
Boehringer Mannheim Corp.
Immunology · 61d
Cleared Mar 24, 1998
QUANTA LITE B2 GPI SCREEN
K980230 · MSV
Inova Diagnostics, Inc.
Immunology · 61d
Cleared Mar 18, 1998
ELECSYS CA 125 II
K972162 · LTK
Boehringer Mannheim Corp.
Immunology · 282d
Cleared Mar 17, 1998
IMMUSTRIP HAMA IGG
K972873 · DAK
Immunomedics, Inc.
Immunology · 225d
Cleared Mar 06, 1998
DIAMEDIX IS-RF TEST SYSTEM
K974889 · DHR
Diamedix Corp.
Immunology · 66d
Cleared Mar 06, 1998
ACS 180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM)
K980190 · MOI
Chiron Corp.
Immunology · 45d
Cleared Mar 04, 1998
HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRAGEL BENCE JONES/HYDRAGEL 2/4 BENCE...
K972591 · JKM
Morax
Immunology · 236d
Cleared Mar 03, 1998
IS-DSDNA TEST SYSTEM
K974694 · LRM
Diamedix Corp.
Immunology · 77d
Cleared Feb 24, 1998
HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM
K972145 · DHN
Immuno Concepts, Inc.
Immunology · 263d
Cleared Feb 20, 1998
ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229
K974816 · LTJ
Beckman Instruments, Inc.
Immunology · 59d
Cleared Feb 18, 1998
RAPET CRP
K974429 · DCN
Stanbio Laboratory
Immunology · 86d
Cleared Feb 17, 1998
WIELISA MPO ANCA TEST SYSTEM
K974166 · MOB
Wieslab AB
Immunology · 104d
Cleared Feb 17, 1998
WIELISA PR-3 ANCA TEST SYSTEM
K974167 · MOB
Wieslab AB
Immunology · 104d
Cleared Feb 17, 1998
WIELISA ANTI-GBM TEST SYSTEM
K974169 · DBL
Wieslab AB
Immunology · 104d
Cleared Feb 17, 1998
RAPET RF
K974370 · DHR
Stanbio Laboratory
Immunology · 89d