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
7633–7656 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Dec 19, 1988
CREATININE TEST (CREA) ITEM #65663
K884734 · CGX
Em Diagnostic Systems, Inc.
Chemistry · 35d
Cleared Dec 16, 1988
HDL-CHOLESTEROL PRECIPITATING REAGENT
K883543 · CHH
Medical Analysis Systems, Inc.
Chemistry · 119d
Cleared Dec 16, 1988
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (FE)
K884355 · JIY
Eastman Kodak Company
Chemistry · 60d
Cleared Dec 16, 1988
PHOSPHORUS TEST (PHOS) ITEM #65666
K884735 · CEO
Em Diagnostic Systems, Inc.
Chemistry · 32d
Cleared Dec 15, 1988
ABC FP ANALYZER
K883533 · JJE
Intl. Bioclinical, Inc.
Chemistry · 119d
Cleared Dec 15, 1988
THYROID STIMULATING HORMONE (HTSH) IRMA NEONATAL
K883726 · JLW
Immuchem Corp.
Chemistry · 106d
Cleared Dec 15, 1988
TOTAL BILIRUBIN REAGENT KIT FOR ASTRA SYSTEMS
K884224 · CIG
A-Kem, Inc.
Chemistry · 70d
Cleared Dec 15, 1988
LYPHOCHEK ROUTINE URINE CONTROLS 1 & 2 (HUMAN)
K884424 · JJW
Bio-Rad
Chemistry · 56d
Cleared Dec 15, 1988
UNIVERSAL(TM) ION SELECT ELECTRODE STANDARDS
K884693 · JIX
Biomedical Research & Development...
Chemistry · 36d
Cleared Dec 14, 1988
RAICHEM(TM) BILIRUBIN CONJUGATE STANDARD
K883389 · JIW
Reagents Applications, Inc.
Chemistry · 126d
Cleared Dec 14, 1988
DELFIA THYROXINE (T4) KIT
K883559 · CDX
Pharmacia, Inc.
Chemistry · 117d
Cleared Dec 14, 1988
PUMPETTE(TM)
K884111 · JKA
Helena Laboratories
Chemistry · 76d
Cleared Dec 14, 1988
DOCUMENT(TM) CHOLESTEROL CALIBRATOR SET
K884197 · JIT
Casco Standards
Chemistry · 69d
Cleared Dec 14, 1988
FIAGEN TBG TIME-RESOLVED FLUOROIMMUNOASSAY KIT
K884201 · CEE
Cyberfluor, Inc.
Chemistry · 69d
Cleared Dec 14, 1988
VERSABLOT
K884258 · KPA
American Bionetics, Inc.
Chemistry · 64d
Cleared Dec 14, 1988
ASPARTATE AMINOTRANSFERASE TEST ITEM NO. 65654
K884377 · CIT
Em Diagnostic Systems, Inc.
Chemistry · 57d
Cleared Dec 14, 1988
TOTAL IRON BINDING CAPACITY TEST
K884649 · JQE
Sclavo, Inc.
Chemistry · 37d
Cleared Dec 09, 1988
IDS-1600 SAMPLE HANDLING SYSTEM
K883470 · JQW
Baxter Healthcare Corp
Chemistry · 116d
Cleared Dec 09, 1988
ACCUCHEK II FREEDOM(TM) MONITORING SYSTEM
K883817 · CGA
Boehringer Mannheim Corp.
Chemistry · 92d
Cleared Dec 09, 1988
ROCHE REAGENT FOR CHLORIDE
K884013 · CHJ
Roche Diagnostic Systems, Inc.
Chemistry · 78d
Cleared Dec 09, 1988
TOTAL PROTEIN REAGENT KIT FOR ASTRA SYSTEMS
K884225 · CEK
A-Kem, Inc.
Chemistry · 64d
Cleared Dec 09, 1988
AMYLASE REAGENT KIT FOR ASTRA SYSTEMS
K884226 · CJA
A-Kem, Inc.
Chemistry · 64d
Cleared Dec 09, 1988
CALIBRATOR STANDARD KIT FOR ASTRA SYSTEM
K884227 · JIX
A-Kem, Inc.
Chemistry · 64d
Cleared Dec 09, 1988
SERUM HCG MICROASSAY
K884430 · DHA
Diamedix Corp.
Chemistry · 49d