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
8929–8952 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared May 29, 1986
ALKALINE PHOSPHATASE PROCEDURE
K861667 · CJE
Data Medical Associates, Inc.
Chemistry · 29d
Cleared May 29, 1986
GAMMA GLUTAMYL TRANSFERASE PROCEDURE
K861672 · JPZ
Data Medical Associates, Inc.
Chemistry · 29d
Cleared May 29, 1986
ACID PHOSPHATASE PROCEDURE
K861675 · CKB
Data Medical Associates, Inc.
Chemistry · 29d
Cleared May 29, 1986
AMYLASE REAGENT CATALOGUE NOS. 85108 AND 85109
K861718 · JFJ
Reagents Applications, Inc.
Chemistry · 28d
Cleared May 29, 1986
CK/LD BUFFER (CAT. NO. 5808)
K861750 · CFE
Helena Laboratories
Chemistry · 23d
Cleared May 29, 1986
CK REAGENT CARTRIDGE (PRODUCT NO. 88213)
K861879 · CGS
Hi Chem, Inc.
Chemistry · 14d
Cleared May 27, 1986
MAGNESIUM PROCEDURE
K861668 · JGJ
Data Medical Associates, Inc.
Chemistry · 27d
Cleared May 27, 1986
SODIUM, POTASSIUM AND CHLORIDE PROCEDURE
K861669 · CGZ
Data Medical Associates, Inc.
Chemistry · 27d
Cleared May 23, 1986
EMDS AMYLASE (AMYL) TEST PACKS, # 67653/95
K860935 · CIJ
Em Diagnostic Systems, Inc.
Chemistry · 72d
Cleared May 23, 1986
QUANTIMETRIX HUMAN BILIRUBIN CONTROL I & II LIQUID
K860942 · JJY
Quantimetrix Corp.
Chemistry · 72d
Cleared May 23, 1986
MMS T3 UPTAKE
K861262 · KHQ
Micromedic Systems
Chemistry · 49d
Cleared May 23, 1986
DIRECT READOUT MODULE ACCESSORY
K861412 · JQP
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 38d
Cleared May 23, 1986
ALBUMIN (BCG) REAGENT
K861467 · CIX
Sigma Diagnostics, Inc.
Chemistry · 32d
Cleared May 23, 1986
EMDS, CK/CK-MB VERIFIER, ITEM NUMBER 67---/95
K861512 · JJT
Em Diagnostic Systems, Inc.
Chemistry · 30d
Cleared May 23, 1986
CONTROL SERA LEVEL VALUES (MG/DL)
K861567 · JJY
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 25d
Cleared May 23, 1986
TOTAL IRON BINDING CAPACITY PROCEDURE
K861602 · CFM
Data Medical Associates, Inc.
Chemistry · 24d
Cleared May 23, 1986
IRON PROCEDURE
K861603 · JJY
Data Medical Associates, Inc.
Chemistry · 24d
Cleared May 23, 1986
MODUMATIC (R) DILUTER
K861640 · JQW
Tri-Continent Scientific, Inc.
Chemistry · 23d
Cleared May 23, 1986
GLUCOSE HK PROCEDURE
K861653 · CGA
Data Medical Associates, Inc.
Chemistry · 23d
Cleared May 23, 1986
SERUM POTASSIUM REAGENT SET
K861713 · CEJ
Sterling Diagnostics, Inc.
Chemistry · 18d
Cleared May 09, 1986
BIOTEL (TM)/UTI
K855238 · JMT
American Diagnostic Corp.
Chemistry · 129d
Cleared May 07, 1986
EMIT COLUMN DIGOXIN CALIBRATORS
K861395 · DLJ
Syva Co.
Chemistry · 23d
Cleared May 05, 1986
VISION SGOT (AST) - ADDIT. OF WHOLE BLOOD CLAIM
K860465 · CIT
Abbott Laboratories
Chemistry · 88d
Cleared May 05, 1986
MINI-CHEM ANALYZER
K860987 · JJQ
Ocean Scientific, Inc.
Chemistry · 49d