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: Chemistry ×
13,237 results
9073–9096 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Feb 28, 1986
SUCROSEP HUMAN GROWTH HORMONE (HGH) IRMA
K860228 · CFL
Boots-Celltech Diagnostics, Inc.
Chemistry · 37d
Cleared Feb 28, 1986
LACTATE DEHYDROGENASE (LDH) REAGENT SET
K860349 · CFH
Sterling Diagnostics, Inc.
Chemistry · 29d
Cleared Feb 28, 1986
AMYLASE REAGENT SET (MODIFIED CARAWAY)
K860530 · CJA
Sterling Diagnostics, Inc.
Chemistry · 16d
Cleared Feb 21, 1986
RASCAL ANESTHESIA RESPIRATORY GAS ANALYZOR
K855108 · JJQ
Biomaterials International, Inc.
Chemistry · 60d
Cleared Feb 21, 1986
EASY-TEST UREA (BUN) REAGENT
K860135 · CDQ
Em Diagnostic Systems, Inc.
Chemistry · 38d
Cleared Feb 21, 1986
DIRECT BILIRUBIN
K860257 · CIG
Pointe Scientific, Inc.,
Chemistry · 28d
Cleared Feb 20, 1986
PHOTIC-100 SPECTROPHOTOMETER
K854679 · JJQ
Future Impex Corp.
Chemistry · 92d
Cleared Feb 19, 1986
ENZYNATIC TRIGLYCERIDES REAGENT SET
K855164 · CDT
Sterling Diagnostics, Inc.
Chemistry · 55d
Cleared Feb 19, 1986
PARAMAX COMPREHENSIVE CALIBRATOR
K855199 · JIX
American Dade
Chemistry · 54d
Cleared Feb 19, 1986
URIC ACID REAGENT SET
K860111 · LFQ
Technostics Intl.
Chemistry · 37d
Cleared Feb 19, 1986
TESTOSTERONE COATED TUBES RADIOIMMUNOASSAY KIT
K860130 · CDZ
Cambridge Medical Technology
Chemistry · 36d
Cleared Feb 19, 1986
SERUM ALBUMIN (BCG) REAGENT SET
K860340 · CIX
Sterling Diagnostics, Inc.
Chemistry · 21d
Cleared Feb 19, 1986
ACE CONTROLS, NORMAL & ELEVATED, NO. A6040 & A7040
K860453 · JJX
Sigma Diagnostics, Inc.
Chemistry · 14d
Cleared Feb 18, 1986
MAGNESIUM REAGENT SET
K855190 · JGJ
Technostics Intl.
Chemistry · 54d
Cleared Feb 13, 1986
TERUMO SENSIBEAD EIG HCG KIT
K854670 · JHJ
Terumo Medical Corp.
Chemistry · 84d
Cleared Feb 11, 1986
EMDS GLUCOSE TEST PACK ITEM 67656/95
K855080 · LFR
Em Diagnostic Systems, Inc.
Chemistry · 54d
Cleared Feb 11, 1986
COMPUTING SPECTROPHOTOMETER BIO-CHEMISTRY ANALYZER
K855149 · JJQ
Hyperion, Inc.
Chemistry · 47d
Cleared Feb 11, 1986
DIMENSION(TM) CLINICAL CHEMISTRY SYSTEM
K860021 · JJE
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 39d
Cleared Feb 11, 1986
CALCIUM (CPC) REAGENT SET
K860044 · CIC
Sterling Diagnostics, Inc.
Chemistry · 36d
Cleared Feb 11, 1986
CPK REAGENT SET (COLORIMETRIC)
K860096 · CGS
Sterling Diagnostics, Inc.
Chemistry · 32d
Cleared Feb 11, 1986
GLUTAMIC PYRUVIC TRANSAMINASE, GPT(UV) REAGENT SET
K860110 · CKA
Technostics Intl.
Chemistry · 29d
Cleared Feb 11, 1986
URIC ACID REAGENT SET (COLORIMETRIC)
K860142 · LFQ
Sterling Diagnostics, Inc.
Chemistry · 28d
Cleared Feb 11, 1986
QWIKSPIN (TM)
K860172 · JQC
Norfolk Scientific, Inc.
Chemistry · 25d
Cleared Feb 11, 1986
ALBUMIN REAGENT KIT
K860213 · CIX
Bio-Analytics Laboratories, Inc.
Chemistry · 20d