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.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,249 results
13033–13056 of 13,249
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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
Cleared Apr 08, 1977
DIGITAL SCANNER
K770526 · JXR
The Perkin-Elmer Corp.
Chemistry · 21d
Cleared Apr 05, 1977
ANALYZER, 751 KINETIC/ENDPOINT
K770306 · JJQ
Sclavo, Inc.
Chemistry · 48d
Cleared Apr 05, 1977
MICRO/PETTOR, SMI
K770307 · JQW
Lederle Laboratories
Chemistry · 58d
Cleared Apr 05, 1977
CHEMISTRY CONTROL, NORMAL
K770310 · JJY
Icn Pharmaceuticals, Inc.
Chemistry · 48d
Cleared Apr 05, 1977
CHEMISTRY CONTROL, ABNORMAL
K770312 · JJY
Icn Pharmaceuticals, Inc.
Chemistry · 48d
Cleared Apr 05, 1977
REAGENT LDH-L, ENZYME
K770313 · CFJ
Icn Pharmaceuticals, Inc.
Chemistry · 48d