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.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,249 results
12505–12528 of 13,249
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Oct 24, 1978
CHOLESTEROL DET. IN SERUM
K781611 · CGO
Fisher Scientific Co., LLC
Chemistry · 35d
Cleared Oct 24, 1978
SODIUM CHLORIDE, 0.85%
K781734
Bioscientific
Chemistry · 12d
Cleared Oct 17, 1978
RIA DIAG. TEST KIT FOR INDEXING THYROX.
K781560 · CEC
Nuclear Diagnostics, Inc.
Chemistry · 36d
Cleared Oct 17, 1978
RIA CONTROLS
K781593 · JJY
Dade, Baxter Travenol Diagnostics, Inc.
Chemistry · 29d
Cleared Oct 11, 1978
EARLY PREGNANCY DETECTION KIT
K781487 · JHI
Radioassay Systems Laboratories, Inc.
Chemistry · 44d
Cleared Oct 11, 1978
RAD-291
K781554 · JQX
Organon, Inc.
Chemistry · 30d
Cleared Oct 10, 1978
BCG ALBUMIN REAGET
K781441 · CIX
Analytical & Research Chemicals, Inc.
Chemistry · 50d
Cleared Oct 10, 1978
CHLORIDE REAGENT
K781460 · CHJ
Analytical & Research Chemicals, Inc.
Chemistry · 50d
Cleared Oct 10, 1978
RIA QUANT B-HCG TEST KIT
K781578 · JHI
Mallinckrodt Critical Care
Chemistry · 25d
Cleared Oct 10, 1978
TEKNI-CAL
K781601 · KRY
Streck Laboratories, Inc.
Chemistry · 22d
Cleared Oct 03, 1978
STAT ULTRA VIOLET LIQUID
K781432 · JHS
Beckman Instruments, Inc.
Chemistry · 43d
Cleared Oct 03, 1978
DELTA TEST ASSAY, HDL CHLORESTEROL
K781436
Bd Becton Dickinson Vacutainer...
Chemistry · 46d
Cleared Oct 03, 1978
BECKMAN ASTRA SYSTEM
K781442 · JJF
Beckman Instruments, Inc.
Chemistry · 41d
Cleared Oct 03, 1978
AUTOMATED ENZYMATIC TRIGLYCERIDE REAGENT
K781466 · CDT
Fisher Scientific Co., LLC
Chemistry · 40d
Cleared Oct 03, 1978
TRIGLYCERIDES TEST KIT
K781477 · CDT
Mallinckrodt Critical Care
Chemistry · 36d
Cleared Oct 03, 1978
ENZAC INCUBATOR
K781501 · JRG
Bd Becton Dickinson Vacutainer...
Chemistry · 34d
Cleared Oct 03, 1978
SMA/GGT
K781533 · JPZ
Technicon Instruments Corp.
Chemistry · 27d
Cleared Oct 03, 1978
SINGLE VIAL LDH-L TRIS
K781538 · CFJ
Boehringer Mannheim Corp.
Chemistry · 25d
Cleared Oct 03, 1978
EPPENDORF PCP 6121
K781544 · JJQ
Marilyn L. Amick
Chemistry · 25d
Cleared Oct 02, 1978
BIO-PRO UNIT
K781303 · FKR
Bd Becton Dickinson Vacutainer...
Chemistry · 67d
Cleared Sep 27, 1978
IMMO PHASE, THYROID HORMONE
K781409 · JLW
Corning Medical & Scientific
Chemistry · 44d
Cleared Sep 27, 1978
RIALYZE VITAMIN B-12 TEST
K781410 · CDD
Ames Div., Miles Laboratories, Inc.
Chemistry · 44d
Cleared Sep 27, 1978
MITROPHENYL, ALKALINE PHOSPHATES
K781472 · CJE
Beckman Instruments, Inc.
Chemistry · 30d
Cleared Sep 27, 1978
ORTHO*T-3 RIA (PEG) KIT
K781481 · CDP
Ortho Diagnostics, Inc.
Chemistry · 30d