FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Immunology ×
3,792 results
1969–1992 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
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
Cleared Mar 22, 1993
AUTOSTAT ANTI-DSDNA
K925783 · JJX
Cogent Diagnotics , Ltd.
Immunology · 140d
Cleared Mar 18, 1993
AIA-PACK CEA CALIBRATION VERIFICATION TEST SET
K924857 · DHX
Tosoh Medics, Inc.
Immunology · 171d