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
7609–7632 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jan 13, 1989
CALCIUM TEST ITEM NUMBER: SR1009
K884986 · CIC
Em Diagnostic Systems, Inc.
Chemistry · 43d
Cleared Jan 13, 1989
UREA NITROGEN TEST (BUN) ITEM NUMBER: SR1022
K884987 · CDQ
Em Diagnostic Systems, Inc.
Chemistry · 43d
Cleared Jan 13, 1989
GAMMA GLUTAMYL TRANSFERASE TEST (GGT) ITEM: 65664
K884988 · JQB
Em Diagnostic Systems, Inc.
Chemistry · 43d
Cleared Jan 11, 1989
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (LAC)
K884189 · KHP
Eastman Kodak Company
Chemistry · 98d
Cleared Jan 11, 1989
ALANINE AMINOTRANSFERASE TEST ITEM NO. 65652
K884376 · CKA
Em Diagnostic Systems, Inc.
Chemistry · 85d
Cleared Jan 11, 1989
AMYLASE TEST (AMYL) ITEM NUMBER: 65653
K884382 · CIW
Em Diagnostic Systems, Inc.
Chemistry · 85d
Cleared Jan 11, 1989
ALBUMIN TEST (ALB) ITEM #65650
K884705 · CIX
Em Diagnostic Systems, Inc.
Chemistry · 63d
Cleared Jan 11, 1989
CHLORIDE TEST (CL) ITEM #65659
K884706 · CHJ
Em Diagnostic Systems, Inc.
Chemistry · 63d
Cleared Jan 11, 1989
ACETAMINOPHEN (ENZYMATIC RATE), NUMBER 502-13
K885097 · LDP
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 33d
Cleared Jan 09, 1989
SAMPLE IDENTIFICATION STATION MODEL 38010
K884269 · JJJ
Icn Micromedic Systems
Chemistry · 90d
Cleared Jan 03, 1989
-AMYLASE EPS
K882225 · CIJ
Boehringer Mannheim Corp.
Chemistry · 222d
Cleared Jan 03, 1989
MODIFIED TSH IRMA KIT
K883742 · JLW
Pacific Biotech, Inc.
Chemistry · 124d
Cleared Jan 03, 1989
AUTOMATED EIA READER MODEL EL311
K884124 · JJQ
Bio-Tek Instruments, Inc.
Chemistry · 95d
Cleared Jan 03, 1989
GLUCOSE-HK TEST (GLUC-HK) ITEM #65665
K884736 · CFR
Em Diagnostic Systems, Inc.
Chemistry · 50d
Cleared Jan 03, 1989
GLUCOSE LIQUID AMRESCO #4628300 & 4628001L
K884909 · CGA
American Research Products Co.
Chemistry · 41d
Cleared Jan 03, 1989
ALANINE AMINOTRANSFERASE
K884936 · CKA
Catachem, Inc.
Chemistry · 39d
Cleared Dec 29, 1988
SAITRON 430 RANDOM ACCESS CHEMISTRY ANALYZER
K884035 · JJE
Sclavo, Inc.
Chemistry · 97d
Cleared Dec 29, 1988
VIRGO(R) MICROWELL ALT ASSAY
K884784 · CKD
Electro-Nucleonics, Inc.
Chemistry · 44d
Cleared Dec 29, 1988
VISUAL BLOOD GLUCOSE TEST SYSTEM
K884993 · CGA
Diagnostic Systems
Chemistry · 28d
Cleared Dec 27, 1988
FERRITIN SEROZYME IMMUNOENZYMETRIC ASSAY
K884683 · DBF
Serono-Baker Diagnostics, Inc.
Chemistry · 49d
Cleared Dec 27, 1988
ABBOTT SPECTRUM(R) BICARBONATE REAGENT
K884821 · KHS
Abbott Laboratories
Chemistry · 40d
Cleared Dec 22, 1988
AMERLIITE FT4 ASSAY LAN.0006/2006 240/144 TEST KIT
K883123 · CEC
Amersham Corp.
Chemistry · 149d
Cleared Dec 22, 1988
COTUBE LH IRMA ASSAY
K884498 · CEP
Bio-Rad
Chemistry · 57d
Cleared Dec 19, 1988
FIRST RESPONSE 10 MINUTE OVULATION PREDICTOR TEST
K883530 · CEP
Tambrands, Inc.
Chemistry · 123d