Medical Device Manufacturer · US , Mchenry , IL

Pro-Lab, Inc.

27 submissions · 26 cleared · Since 1984
27
Total
26
Cleared
0
Denied

Pro-Lab, Inc. — FDA 510(k) Submissions

Pro-Lab, Inc. has submitted 27 FDA 510(k) premarket notifications since 1984, of which 26 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Supplement, Culture Media, Discs, Strips And Reagents, Microorganism Differentiation, Wrap, Sterilization, Culture Media, Multiple Biochemical Test, Antisera, All Groups, Streptococcus Spp. . Use the specialty filter in the sidebar to narrow results.

27 devices
1–25 of 27
PROLEX (STREPTOCCAL GROUPING LATEX KIT)
K934383 · GTZ Antisera, All Groups,... · Microbiology
Jan 1995 505d
AMNIOTEST(TM)
K914419 · HIO Sampler, Amniotic Fluid... · Chemistry
Sep 1993 699d
LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODY
K921421 · LHL Reagents, Antibody,... · Microbiology
Jul 1992 126d
E. COLI 0157 LATEX TEST
K903714 · GNA Antisera, All Types,... · Microbiology
Jan 1991 163d
ROSCO PYRR
K894221 · JTO Discs, Strips And... · Microbiology
Sep 1989 101d
X-ACT UREA/TDA
K883995 · JSE Culture Media, Multiple... · Microbiology
Oct 1988 22d
X-ACT LDC/IND
K883996 · JSE Culture Media, Multiple... · Microbiology
Oct 1988 22d
PROTECT T.M.
K871121 · JTR Kit, Quality Control For... · Microbiology
Apr 1987 26d
NEISSERIA/BRANHAMELLA DIFFERENTIAL TEST
K870117 · JSX Kit, Identification,... · Microbiology
Mar 1987 67d
MASTER KIT B
K861142 · LRP Tray, Surgical · General & Plastic Surgery
Jul 1986 106d
HIPPURATE HYDROLYSIS TEST
K861888 · JTO Discs, Strips And... · Microbiology
Jun 1986 18d
D'ALA RAPID TEST
K861889 · JTO Discs, Strips And... · Microbiology
Jun 1986 18d
MASTER KIT A
K850246 · General & Plastic Surgery
Apr 1985 77d
SUPLEX & SUPLEX DILUENT
K850302 · JSK Supplement, Culture Media · Microbiology
Mar 1985 59d
C.N.V.T.
K850299 · JSK Supplement, Culture Media · Microbiology
Mar 1985 57d
MUCOLYSE
K850300 · JSK Supplement, Culture Media · Microbiology
Mar 1985 57d
YEAST DIALYSATE
K850301 · JSK Supplement, Culture Media · Microbiology
Mar 1985 57d
CAMPYLOBACTER SUPPLEMENT -SKIRROW
K850306 · JSK Supplement, Culture Media · Microbiology
Mar 1985 57d
CAMPYLOBACTER SUPPLEMENT-BLASER/WANG
K850307 · JSK Supplement, Culture Media · Microbiology
Mar 1985 57d
C.L.A.T.
K850308 · JSK Supplement, Culture Media · Microbiology
Mar 1985 57d
CUSTOM OPEN HEART TRAY
K850072 · General & Plastic Surgery
Mar 1985 65d
INTRAVENOUS START KIT
K843813 · General & Plastic Surgery
Dec 1984 68d
DRESSING CHANGE TRAY STERILE 5002
K842404 · General & Plastic Surgery
Dec 1984 168d
VENESECTION TRAY, ADULT 6050
K843627 · FSM Tray, Surgical, Instrument · General & Plastic Surgery
Dec 1984 81d
SUTURE TRAY
K843525 · General & Plastic Surgery
Nov 1984 59d
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