Medical Device Manufacturer · US , Mchenry , IL

Biosan Laboratories, Inc.

10 submissions · 10 cleared · Since 1983
10
Total
10
Cleared
0
Denied

Biosan Laboratories, Inc. — FDA 510(k) Submissions

Biosan Laboratories, Inc. has submitted 10 FDA 510(k) premarket notifications since 1983, of which 10 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Multi-analyte Controls, All Kinds (assayed), Resins, Ion-exchange, Screen, Tangent, Ac-powered (campimeter), Radioimmunoassay, Tobramycin, Radioimmunoassay, Thyroid-stimulating Hormone . Use the specialty filter in the sidebar to narrow results.

10 devices
1–10 of 10
PHOTRON VISUAL FIELD ANALYZER
K860642 · HOM Screen, Tangent,... · Ophthalmic
Apr 1986 54d
PHOTRON NEUROVISUAL STIMULATOR(MODIFICATION)
K853812 · HLX Photostimulator, Ac-powered · Ophthalmic
Nov 1985 50d
TOBRAMYCIN REAGENT
K832763 · KLB Radioimmunoassay, Tobramycin · Chemistry
Mar 1984 220d
RADIOIMMUNOASSAY, THYROID STIMU. HORMONE
K833193 · JLW Radioimmunoassay,... · Chemistry
Feb 1984 138d
BIO-SCIENCE LABORATORIES T4 REAGENT
K834023 · CDX Radioimmunoassay, Total... · Chemistry
Jan 1984 63d
NORMAL GOAT SERUM
K833318 · DHX System, Test,... · Immunology
Jan 1984 99d
ABNORMAL URINE CONTROL
K833191 · JJY Multi-analyte Controls,... · Chemistry
Dec 1983 80d
NORMAL URINE CONTROL
K833192 · JJY Multi-analyte Controls,... · Chemistry
Dec 1983 80d
AMBERLITE CG50 RESIN, 100-200 MESH
K833320 · KEA Resins, Ion-exchange · Pathology
Dec 1983 73d
BIO-REX 70 RESIN 100-200 MESH PH6.2
K833319 · KEA Resins, Ion-exchange · Toxicology
Nov 1983 38d
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