Medical Device Manufacturer · US , Mchenry , IL

Biovation, Inc.

11 submissions · 11 cleared · Since 1978
11
Total
11
Cleared
0
Denied

Biovation, Inc. — FDA 510(k) Submissions

Biovation, Inc. has submitted 11 FDA 510(k) premarket notifications since 1978, of which 11 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Calculator/data Processing Module, For Clinical Use, Nephelometer, For Clinical Use, Counter, Differential Cell, Refractometer For Clinical Use, Lowry (colorimetric), Total Protein . Use the specialty filter in the sidebar to narrow results.

11 devices
1–11 of 11
BIOVATION K-MANAGER
K925528 · GKZ Counter, Differential Cell · Hematology
Feb 1993 95d
LYRIS 100/120 LABORATORY INFORMATION SYSTEM
K923844 · JJQ Colorimeter, Photometer,... · Chemistry
Dec 1992 133d
DIFFERENTIAL COUNTING BOARD
K915071 · GKZ Counter, Differential Cell · Hematology
Jan 1992 70d
BIOVATION MAX DATA MANAGEMENT SYSTEM
K853026 · JQP Calculator/data... · Chemistry
Aug 1985 15d
CHEMISTRY CONSOLE
K842401 · JQP Calculator/data... · Chemistry
Sep 1984 77d
LYRIS MODULAR INFO SYSTEM
K831830 · JQP Calculator/data... · Chemistry
Jun 1984 384d
HEMATOLOGY DATA MANAGEMENT SYS
K821534 · JGP Lowry (colorimetric),... · Hematology
Jun 1982 17d
BIOVATION URINALYSIS REPORTER
K812604 · JQP Calculator/data... · Chemistry
Oct 1981 17d
BIOVATION NEPHELOMETER
K792045 · JQX Nephelometer, For... · Chemistry
Oct 1979 18d
BIOVATION DIGITAL URINOMETER
K790862 · JRE Refractometer For... · Chemistry
Jun 1979 52d
ANTIBIOTIC NEPHELOMETER
K781644 · JQX Nephelometer, For... · Microbiology
Oct 1978 8d
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