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
7897–7920 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Apr 28, 1988
CHOLESTEROL
K880237 · CHH
Tech-Neal Scientific, Inc.
Chemistry · 99d
Cleared Apr 28, 1988
PREGNANCY BETA-HCG CARD & LIQUID TEST
K880478 · JHJ
Ampcor, Inc.
Chemistry · 84d
Cleared Apr 28, 1988
VACUGUARD(TM)
K880594 · JKA
Habley Medical Technology Corp.
Chemistry · 77d
Cleared Apr 28, 1988
CARBON DIOXIDE ASSAY KIT(ENZY. SINGLE) 203-10
K880866 · KHS
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 58d
Cleared Apr 28, 1988
MICRO CO2 APPARATUS
K880967 · CIE
Hf Scientific, Inc.
Chemistry · 51d
Cleared Apr 28, 1988
PARAMAX IRON REAGENT
K881104 · JIY
Baxter Healthcare Corp
Chemistry · 44d
Cleared Apr 28, 1988
ALLEGRO(TM) FOLLICLE STIMULATING HORMONE IMMUNO.
K881123 · CGJ
Nichols Institute Diagnostics
Chemistry · 43d
Cleared Apr 28, 1988
DIRECT BILIRUBIN PROCEDURE
K881166 · CIG
Data Medical Associates, Inc.
Chemistry · 41d
Cleared Apr 28, 1988
IRON PROCEDURE
K881167 · JIY
Data Medical Associates, Inc.
Chemistry · 41d
Cleared Apr 28, 1988
CARBON DIOXIDE REAGENT
K881169 · KHS
Intersect Systems, Inc.
Chemistry · 41d
Cleared Apr 28, 1988
PHOSPHORUS (INORGANIC)
K881171 · CEO
Tech-Co, Inc.
Chemistry · 38d
Cleared Apr 28, 1988
CHLORIDE LIQUID STABLE REAGENT SET
K881200 · CHJ
Medical Analysis Systems, Inc.
Chemistry · 38d
Cleared Apr 28, 1988
IRON TEST
K881202 · JIY
Sclavo, Inc.
Chemistry · 38d
Cleared Apr 28, 1988
ACP KINETIC TEST (ACID PHOSPHATASE TEST)
K881204 · CKB
Sclavo, Inc.
Chemistry · 38d
Cleared Apr 28, 1988
CREATINE KINASE (CK) REAGENT SET
K881237 · JHX
Tech-Neal Scientific, Inc.
Chemistry · 37d
Cleared Apr 28, 1988
CHLORIDE REAGENT SET
K881240 · CHJ
Tech-Neal Scientific, Inc.
Chemistry · 37d
Cleared Apr 28, 1988
BIOTROL -GT GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST
K881311 · JQB
Biotrol, USA, Inc.
Chemistry · 31d
Cleared Apr 28, 1988
CREATININE FOR CONTINUOUS FLOW INSTRUMENTS
K881400 · CGX
Catachem, Inc.
Chemistry · 24d
Cleared Apr 19, 1988
AMYLASE 405 CATALOG NUMBER 301-34
K880867 · JFJ
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 49d
Cleared Apr 18, 1988
ALBUMIN CAT. # 201-03
K875207 · CIX
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 122d
Cleared Apr 18, 1988
CHLORIDE CAT. # 152-17
K875208 · CHJ
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 122d
Cleared Apr 18, 1988
GLUCOSE (TRINDER) CAT. # 220-32
K875211 · CGA
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 122d
Cleared Apr 18, 1988
ABBOTT IMX T3
K880087 · CDP
Abbott Laboratories
Chemistry · 97d
Cleared Apr 18, 1988
URIC ACID REAGENT SET
K880277 · KNK
Tech-Neal Scientific, Inc.
Chemistry · 88d