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
3721–3744 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Feb 07, 1977
SPAC TM T3 UPTAKE KIT
K770033 · KHQ
Mallinckrodt Critical Care
Immunology · 28d
Cleared Feb 07, 1977
SPAC TM T4 RIA KIT
K770156 · CDX
Mallinckrodt Critical Care
Immunology · 14d
Cleared Feb 01, 1977
ELECTRO IMMUNO ASSAY KIT
K770150 · JZS
Millipore Corp.
Immunology · 8d
Cleared Jan 25, 1977
UNIVAL CONTROL CELLS
K761284 · KSF
Dade, Baxter Travenol Diagnostics, Inc.
Immunology · 36d
Cleared Jan 25, 1977
PIPETTING DEVICES
K770013 · JQW
Kensington Scientific
Immunology · 22d
Cleared Dec 30, 1976
MULTI-TEST
K760699 · SCL
Lincoln Laboratories, Inc.
Immunology · 99d
Cleared Dec 30, 1976
LASER STANDARD SERUM
K761235 · JZW
Behring Diagnostics, Inc.
Immunology · 20d
Cleared Dec 30, 1976
ANTISERUM HUMAN (PRO.) NEPHELOMETRIC GR.
K761236 · JZW
Behring Diagnostics, Inc.
Immunology · 20d
Cleared Dec 30, 1976
ANGIOTENSIN I IMMUTOPE KIT
K761267 · CIB
Squibb & Sons, Inc.
Immunology · 14d
Cleared Dec 30, 1976
IMMUNO-TEC II OT AGAROSE PLATE KIT
K761270 · JZP
Behring Diagnostics, Inc.
Immunology · 14d
Cleared Dec 30, 1976
DATA-TOPE T4 RIA PROCEDURE
K761282 · CDX
Dade, Baxter Travenol Diagnostics, Inc.
Immunology · 10d
Cleared Dec 30, 1976
IMMU-SAL IMMUNOHEMATOLOGICAL SALINE
K761303 · KSS
Dade, Baxter Travenol Diagnostics, Inc.
Immunology · 8d
Cleared Dec 30, 1976
CENTRIA T3 RIA
K761305 · CDP
Union Carbide Corp.
Immunology · 8d
Cleared Dec 30, 1976
OB-GYN CONTROL SERA (CODE 196300)
K761309 · JIX
Amersham Corp.
Immunology · 7d
Cleared Dec 30, 1976
ACCRAASSAY RID KITS
K761311 · JZQ
Miles Laboratories, Inc.
Immunology · 7d
Cleared Dec 22, 1976
TOBRAMYCIN RIA KIT
K760967 · KLB
Diagnostic Products Corp.
Immunology · 48d
Cleared Dec 19, 1976
RAPI/TEX-LGM KIT
K760673 · DFT
Hoechst-Roussel Pharmaceuticals, Inc.
Immunology · 90d
Cleared Nov 19, 1976
TEST SYSTEM, THYROID STIM. HORMONE ASSAY
K760255 · JLW
Corning Medical & Scientific
Immunology · 31d
Cleared Nov 19, 1976
PHADEBAS T4 RIA
K760955
Pharmacia, Inc.
Immunology · 17d
Cleared Nov 16, 1976
FUNGAL IMMUNODIFFUSION KIT
K760825
I M, Inc.
Immunology · 34d
Cleared Nov 16, 1976
POTASSIUM HYDROXIDE W/GLYCEROL MTG FL.
K760837
I M, Inc.
Immunology · 34d
Cleared Nov 16, 1976
LACTO-PHENOL COTTON BLUE MOUNTING FL.
K760838 · LEB
I M, Inc.
Immunology · 34d
Cleared Nov 16, 1976
VASPAR, SEALANT FOR FERMENTATIONS
K760839
I M, Inc.
Immunology · 34d
Cleared Nov 16, 1976
TEST FOR DETECTION OF ANTIRUBELLA ANTIB
K760889 · GOL
Abbott Laboratories
Immunology · 21d