Medical Device Manufacturer · US , Mchenry , IL

Alpha-Tec Systems, Inc.

18 submissions · 18 cleared · Since 1983
18
Total
18
Cleared
0
Denied

Alpha-Tec Systems, Inc. — FDA 510(k) Submissions

Alpha-Tec Systems, Inc. has submitted 18 FDA 510(k) premarket notifications since 1983, of which 18 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Stains, Microbiologic, Quality Control Slides, Fixative, Alcohol Containing, Supplement, Culture Media, Fixative, Acid Containing . Use the specialty filter in the sidebar to narrow results.

18 devices
1–18 of 18
PARA-PRO FC50
K053257 · LKS Device, Parasite... · Microbiology
May 2006 171d
ATS DOBELL & O'CONNOR'S IODINE
K890861 · JTS Stains, Microbiologic · Pathology
Mar 1989 30d
ATS LUGOL'S IODINE SOLUTION
K890020 · JTS Stains, Microbiologic · Pathology
Feb 1989 51d
ATS TB RAPID STAIN SET PRODUCT #034-45
K890148 · ICL Carbol Fuchsin · Pathology
Jan 1989 11d
ATS MAYER'S ALBUMIN
K890022 · KEL Adhesive, Albumin-based · Pathology
Jan 1989 6d
ATS PARA-SET MODIFIED PVA FIXATIVE SOLUTION
K883048 · LDZ Fixative, Alcohol Containing · Pathology
Aug 1988 32d
ATS PARA-SET IODINE ALCOHOL SOLUTION
K883049 · JTS Stains, Microbiologic · Pathology
Aug 1988 29d
ATS SCHAUDINN'S FIXATIVE W/ACETIC ACID
K883062 · LDW Fixative, Acid Containing · Pathology
Aug 1988 16d
ATS NAC-PAC SET
K881949 · JSK Supplement, Culture Media · Microbiology
May 1988 15d
ATS CRYPTOSPORIDIUM STAIN SET
K880989 · JTS Stains, Microbiologic · Pathology
May 1988 66d
ATS PVA FIXATIVE SOLUTION
K881698 · LDZ Fixative, Alcohol Containing · Pathology
May 1988 24d
ATS M/15 PHOSPHATE BUFFER, PRODUCT #034-42
K881879 · JSK Supplement, Culture Media · Pathology
May 1988 9d
ATS CRYPTOSPORIDIUM STAIN CONTROL SLIDES
K880962 · LJG Quality Control Slides · Microbiology
Mar 1988 22d
ATS TRICHROME STAIN (WHEATLEY'S MODIFICATION)
K881042 · JTS Stains, Microbiologic · Pathology
Mar 1988 19d
ATS 0.2% BOVINE ALBUMIN FRACTION V SOLUTION
K880990 · JSY Kit, Identification,... · Pathology
Mar 1988 16d
ATS GRAM STAIN CONTROL SLIDE
K823704 · LJG Quality Control Slides · Hematology
Jan 1983 29d
ATS PARASITOLOGY STAIN CONTROL SLIDE
K823705 · LJG Quality Control Slides · Hematology
Jan 1983 29d
ATS AFB STAIN CONTROL SLIDE
K823706 · LJG Quality Control Slides · Hematology
Jan 1983 29d
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