Medical Device Manufacturer · US , Mchenry , IL

Pro-Lab, Inc. - FDA 510(k) Cleared Devices

27 submissions · 26 cleared · Since 1984

Recent clearances: PROLEX (STREPTOCCAL GROUPING LATEX KIT), AMNIOTEST(TM), LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODY

27
Total
26
Cleared
0
Denied

FDA 510(k) Regulatory Record - Pro-Lab, Inc. General & Plastic Surgery ✕

7 devices
1-7 of 7
Cleared Jul 10, 1986
MASTER KIT B
K861142 · LRP
General & Plastic Surgery · 106d
Cleared Apr 09, 1985
MASTER KIT A
K850246
General & Plastic Surgery · 77d
Cleared Mar 15, 1985
CUSTOM OPEN HEART TRAY
K850072
General & Plastic Surgery · 65d
Cleared Dec 05, 1984
INTRAVENOUS START KIT
K843813
General & Plastic Surgery · 68d
Cleared Dec 04, 1984
DRESSING CHANGE TRAY STERILE 5002
K842404
General & Plastic Surgery · 168d
Cleared Dec 04, 1984
VENESECTION TRAY, ADULT 6050
K843627 · FSM
General & Plastic Surgery · 81d
Cleared Nov 05, 1984
SUTURE TRAY
K843525
General & Plastic Surgery · 59d
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All27 Microbiology 17 General & Plastic Surgery 7 General Hospital 2 Chemistry 1