FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,224 results
11209–11232 of 13,224
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Dec 22, 1981
MULTIWASH
K813426 · JQW
Flow Laboratories, Inc.
Chemistry · 15d
Cleared Dec 22, 1981
TRIGLYCERIDE CALIBRATORS
K813478 · JIS
Gilford Diagnostics
Chemistry · 21d
Cleared Dec 22, 1981
PROGESTERONE KIT BY RIA
K813484 · JLS
Immuchem Corp.
Chemistry · 21d
Cleared Dec 18, 1981
DOCUMENT LINEARITY TEST STANDARDS
K813411 · JIX
North American Standards
Chemistry · 14d
Cleared Dec 17, 1981
ASTRA REAGENT CONCENTRATE SYSTEM
K812866 · CGA
Nobel Scientific Industries, Inc.
Chemistry · 65d
Cleared Dec 17, 1981
ANDRIA-FSH RIA TEST KIT
K813086 · CGJ
Intl. Immunoassay Laboratories, Inc.
Chemistry · 45d
Cleared Dec 17, 1981
ABURIA-CK RIA TEST KIT
K813087 · JHX
Intl. Immunoassay Laboratories, Inc.
Chemistry · 45d
Cleared Dec 17, 1981
SECURE FDI TEST KIT
K813216 · JHG
Beckman Instruments, Inc.
Chemistry · 38d
Cleared Dec 17, 1981
RIAGEN PAP RIA
K813261 · JFH
Biogenex Laboratories
Chemistry · 27d
Cleared Dec 17, 1981
A-1 IN-HOME PREGNANCY TEST
K813272 · LCX
C.F. Medical, Inc.
Chemistry · 27d
Cleared Dec 17, 1981
ORTHO CO2 DILUENT LEVEL I
K813293 · JJY
Ortho Diagnostic Systems, Inc.
Chemistry · 24d
Cleared Dec 17, 1981
ORTHO CO2 DILUENT LEVEL II
K813294 · JJY
Ortho Diagnostic Systems, Inc.
Chemistry · 24d
Cleared Dec 17, 1981
ORTHO CO2 DILUENT LEVEL III
K813295 · JJY
Ortho Diagnostic Systems, Inc.
Chemistry · 24d
Cleared Dec 17, 1981
NO-HOIL COMBOSTAT II KIT
K813310 · CDD
Ria Products, Inc.
Chemistry · 23d
Cleared Dec 17, 1981
MINI-SHAKER
K813318 · JRQ
Dynatech Corp.
Chemistry · 23d
Cleared Dec 17, 1981
ORTHO* UNASSAYED CONTROL SERUM LEVEL I
K813321 · JJY
Ortho Diagnostic Systems, Inc.
Chemistry · 23d
Cleared Dec 17, 1981
ORTHO* UNASSAYED CONTROL SERUM LEVEL III
K813322 · JJY
Ortho Diagnostic Systems, Inc.
Chemistry · 23d
Cleared Dec 10, 1981
BECKMAN SYSTEM E4A
K813160 · JJE
Beckman Instruments, Inc.
Chemistry · 24d
Cleared Dec 08, 1981
VACUSHIELD TM
K813159 · JRL
Gelman Sciences, Inc.
Chemistry · 22d
Cleared Dec 08, 1981
Y-GLUTAMYLTRANSFERASE
K813215
American Monitor Corp.
Chemistry · 29d
Cleared Dec 08, 1981
UV URIC ACID DETERMINATION
K813244 · CDO
Biorent Diagnostic, Inc.
Chemistry · 20d
Cleared Dec 03, 1981
CREATININE REAGENT SET
K812834 · CGX
Anco Medical Reagents & Assoc.
Chemistry · 55d
Cleared Dec 03, 1981
TRIGLYCERIDE REAGENT SET
K812838 · CDT
Anco Medical Reagents & Assoc.
Chemistry · 55d
Cleared Dec 03, 1981
HDL CHOLESTEROL REAGENT SET
K812839 · LBR
Anco Medical Reagents & Assoc.
Chemistry · 55d