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
1969–1992 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared May 20, 1993
HEP-2 ANTINUCLEAR ANTIBODY TEST SYSTEM
K926114 · DHN
Tissue Culture Biotec, Inc.
Immunology · 168d
Cleared May 20, 1993
VIDAS TOTAL IGE (IGE) ASSAY
K931224 · DGP
Biomerieux Vitek, Inc.
Immunology · 71d
Cleared May 19, 1993
ELISA-DPXA SSA KIT
K924945 · LLL
Advanced Biological Products, Inc.
Immunology · 231d
Cleared May 19, 1993
ELISA-DOXA SSB
K924946 · LLL
Advanced Biological Products, Inc.
Immunology · 231d
Cleared May 19, 1993
ELISA-DOXA SM
K924947 · LLL
Advanced Biological Products, Inc.
Immunology · 231d
Cleared May 19, 1993
ELISA-DOXA SM/RNP
K924948 · LLL
Advanced Biological Products, Inc.
Immunology · 231d
Cleared May 19, 1993
ELISA-DOXA SCL-70
K924949 · LLL
Advanced Biological Products, Inc.
Immunology · 231d
Cleared May 19, 1993
ELISA-DOXA JO-1
K924950 · LLL
Advanced Biological Products, Inc.
Immunology · 231d
Cleared May 19, 1993
ELISA-DOXA COMBI-4
K924951 · LLL
Advanced Biological Products, Inc.
Immunology · 231d
Cleared May 19, 1993
ELISA-DOXA COMBI-6
K924952 · LLL
Advanced Biological Products, Inc.
Immunology · 231d
Cleared May 14, 1993
AIA-PACK IGE CALIBRATION VERIFICATION TEST SET
K924859 · JJX
Tosoh Medics, Inc.
Immunology · 228d
Cleared May 14, 1993
VENTREX ALLERGEN DISC
K925044 · DHB
Ventrex, Inc.
Immunology · 221d
Cleared May 14, 1993
THYROID PEROXIDASE AUTO ANTIBODIES(TPO) IMMUN KIT
K931311 · JZO
Nichols Institute
Immunology · 60d
Cleared May 11, 1993
SYNELISA SM ABS/RNP-SM ABS
K930141 · LKP
Elias U.S.A., Inc.
Immunology · 119d
Cleared May 11, 1993
SYNELISA U1-SNRNP (68KDA)-ANTIBODIES
K930142 · LKO
Elias U.S.A., Inc.
Immunology · 119d
Cleared May 11, 1993
AYNELISA M2-ANTIBODIES
K930143 · DBM
Elias U.S.A., Inc.
Immunology · 119d
Cleared Apr 27, 1993
TITAN GEL IMMUNOFIX-9 CAT. NO. 3051 AND 3067
K931247 · DAH
Helena Laboratories
Immunology · 47d
Cleared Apr 08, 1993
THYROGLOBULIN AUTOANTIBODY IMMUNOASSAY KIT
K930777 · JNL
Nichols Institute
Immunology · 51d
Cleared Apr 06, 1993
IMMUNO RA UNDILUTED
K926569 · DHR
Immunostics Co., Inc.
Immunology · 96d
Cleared Apr 06, 1993
SYNELISA JO-1 ANTIBODIES
K930281 · LLL
Elias U.S.A., Inc.
Immunology · 75d
Cleared Apr 06, 1993
SYNELISA SCL-70 ANTIBODIES
K930417 · LLL
Elias U.S.A., Inc.
Immunology · 70d
Cleared Mar 26, 1993
RHEUMELISA II JO-1 ANTIBODY TEST KIT
K930757 · LLL
Biowhittaker Molecular Applications,...
Immunology · 42d
Cleared Mar 23, 1993
RHEUMELISA II SCL-70 ANTIBODY TEST KIT
K930130 · LLL
Biowhittaker Molecular Applications,...
Immunology · 70d
Cleared Mar 22, 1993
ANTI-DSDNA ANTIBODY TEST
K921658 · LSW
Immco Diagnostics, Inc.
Immunology · 349d