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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,231 results
13009–13032 of 13,231
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared May 10, 1977
BILIRUBIN PROCEDURE, TEKPOINT TOT & DIR.
K770458 · CIG
Icn Pharmaceuticals, Inc.
Chemistry · 63d
Cleared May 09, 1977
SMAC SYSTEM
K770508 · JCC
Mid Tech, Inc.
Chemistry · 53d
Cleared May 06, 1977
IN VITRO DIAGNOSTIC REAGENTS
K770506 · JJC
Norwood Scientific Associates, Inc.
Chemistry · 51d
Cleared May 03, 1977
URINALYSIS PROFICIENCY
K770390 · JJW
Miles Laboratories, Inc.
Chemistry · 64d
Cleared May 03, 1977
CALCIUM PROCEDURE, TEKPOINT DIRECT
K770449 · CIC
Icn Pharmaceuticals, Inc.
Chemistry · 56d
Cleared May 03, 1977
CHLORIDE PROCEDURE, TEKPOINT DIRECT
K770450 · CHJ
Icn Pharmaceuticals, Inc.
Chemistry · 56d
Cleared May 03, 1977
ALBUMIN PROCEDURE, TEKPOINT BROMCRESOL
K770451 · CIX
Icn Pharmaceuticals, Inc.
Chemistry · 56d
Cleared May 03, 1977
PROTEIN PROCEDURE, TEKPOINT TOTAL
K770452 · CEK
Icn Pharmaceuticals, Inc.
Chemistry · 56d
Cleared May 03, 1977
PHOSPHATASE PROCEDURE, TEKPOINT ALKALINE
K770453 · CIO
Icn Pharmaceuticals, Inc.
Chemistry · 56d
Cleared May 03, 1977
CREATININE PROCEDURE, TEKPOINT
K770454 · CGX
Icn Pharmaceuticals, Inc.
Chemistry · 56d
Cleared May 03, 1977
GLUCOSE PROCEDURE, TEKPOINT DIRECT
K770455 · CGE
Icn Pharmaceuticals, Inc.
Chemistry · 56d
Cleared May 03, 1977
PHOSPHOROUS, INORGANIC, TEKPOINT DIRECT
K770456 · CEO
Icn Pharmaceuticals, Inc.
Chemistry · 56d
Cleared May 03, 1977
CHOLESTEROL PROCEDURE, TEKPOINT TOTAL
K770457 · CGO
Icn Pharmaceuticals, Inc.
Chemistry · 56d
Cleared May 03, 1977
CHEMISTRY, COULTER
K770679 · JJE
Coulter Electronics, Inc.
Chemistry · 22d
Cleared Apr 29, 1977
URIC ACID PROCEDURE, TEKPOINT DIRECT
K770459 · CDH
Icn Pharmaceuticals, Inc.
Chemistry · 52d
Cleared Apr 26, 1977
PROPANE, HIGH PURITY, INSTRUMENT GRADE
K770393 · JJO
Hycel, Inc.
Chemistry · 57d
Cleared Apr 26, 1977
REAGENT, AMYLASE LIPASE
K770400 · KHM
Bd Becton Dickinson Vacutainer...
Chemistry · 55d
Cleared Apr 26, 1977
LDH/NADH,LDH/NADH, NAD & NAD DIAPHORASE
K770401 · JJI
Bd Becton Dickinson Vacutainer...
Chemistry · 55d
Cleared Apr 15, 1977
METER, PH, DIGITAL, MODEL 3560
K770347 · JQY
Beckman Instruments, Inc.
Chemistry · 52d
Cleared Apr 15, 1977
ACA LIPASE ANALYTICAL TEST PACK
K770364 · CET
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 51d
Cleared Apr 15, 1977
CHEMISTRY CONTROL-LOW & HIGH TQC TM
K770380 · JJY
Technicon Instruments Corp.
Chemistry · 49d
Cleared Apr 15, 1977
BLOOD GAS ANALYZER-CALIBRATION GAS
K770494 · JIX
Gardner Cryogenics
Chemistry · 32d
Cleared Apr 08, 1977
METER, IV PH, MODEL EXPANDOMATIC
K770352 · JQY
Beckman Instruments, Inc.
Chemistry · 45d
Cleared Apr 08, 1977
ACA AMMONIA ANALYTICAL TEST PACK
K770363 · JIF
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 44d