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
1297–1320 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Nov 04, 1998
C4
K983356 · DBI
Abbott Laboratories
Immunology · 41d
Cleared Nov 04, 1998
IGA
K983359 · CZP
Abbott Laboratories
Immunology · 41d
Cleared Nov 04, 1998
C3
K983441 · CZW
Abbott Laboratories
Immunology · 35d
Cleared Oct 27, 1998
ELECSYS PSA, MODEL # ELECSYS 1010
K982948 · LTJ
Boehringer Mannheim Corp.
Immunology · 67d
Cleared Oct 27, 1998
ELECSYS PSA, MODEL 2010
K982949 · LTJ
Boehringer Mannheim Corp.
Immunology · 67d
Cleared Oct 27, 1998
FERRITIN CALIBRATOR
K983548 · JIT
Dade Behring, Inc.
Immunology · 18d
Cleared Oct 22, 1998
MONKEY OESOPHAGUS IFA DIAGNOSTIC TEST KITS
K981209 · MVM
The Binding Site, Ltd.
Immunology · 203d
Cleared Oct 22, 1998
UNICAP GLIADIN IGA ASSAY
K982533 · MST
Pharmacia & Upjohn Co.
Immunology · 94d
Cleared Oct 22, 1998
UNICAP GLIADIN IGG ASSAY
K982701 · MST
Pharmacia & Upjohn Co.
Immunology · 94d
Cleared Oct 22, 1998
BAYER IMMUNO 1 SYSTEM FERRITIN ASSAY
K982714 · DBF
Bayer Corp.
Immunology · 79d
Cleared Oct 21, 1998
TFR
K981208 · JNM
Ramco Laboratories, Inc.
Immunology · 202d
Cleared Oct 16, 1998
TINAQUANT B 2-MICROGLOBULIN ASSAY
K980724 · JZG
Boehringer Mannheim Corp.
Immunology · 234d
Cleared Oct 16, 1998
NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID PEROXIDASE AUTOANTIBODIES...
K982866 · JZO
Nichols Institute Diagnostics
Immunology · 63d
Cleared Oct 15, 1998
CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY
K982680 · MOI
Chiron Diagnostics Corp.
Immunology · 76d
Cleared Oct 15, 1998
SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (ELISA) ASSAY
K982879 · MSV
Shield Diagnostics, Ltd.
Immunology · 62d
Cleared Oct 15, 1998
IMMULITE 2000 OM-MA MODEL L2KOP2
K983391 · LTK
Diagnostic Products Corp.
Immunology · 20d
Cleared Oct 13, 1998
BIOCIRCUITS IOS PROSTATE SPECIFIC ANTIGEN (PSA) TEST CARTRIDGES, BIOCIRCUITS...
K981634 · LTJ
Biocircuits Corp.
Immunology · 158d
Cleared Oct 08, 1998
AIA-PACK TPOAB ASSAY
K981521 · JZO
Tosoh Medics, Inc.
Immunology · 163d
Cleared Oct 08, 1998
AIA-PACK TGAB ASSAY
K981522 · JZO
Tosoh Medics, Inc.
Immunology · 163d
Cleared Oct 07, 1998
HYDRAGEL 6 CSF KIT
K981048 · CFF
Morax
Immunology · 201d
Cleared Oct 07, 1998
QUANTA LITE CHROMATIN ELISA
K982603 · LLL
Inova Diagnostics, Inc.
Immunology · 72d
Cleared Sep 30, 1998
THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG...
K973203 · DAK
Sangstat Medical Corp.
Immunology · 400d
Cleared Sep 29, 1998
LIQUID IMMUNOLOGY CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS
K983130 · JJY
Kamiya Biomedical Co.
Immunology · 21d
Cleared Sep 29, 1998
ASO/CRP/RF CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS
K983241 · JJY
Kamiya Biomedical Co.
Immunology · 14d