Medical Device Manufacturer · US , Mchenry , IL

Sclavo, Inc.

82 submissions · 82 cleared · Since 1977
82
Total
82
Cleared
0
Denied

Sclavo, Inc. — FDA 510(k) Submissions

Sclavo, Inc. has submitted 82 FDA 510(k) premarket notifications since 1977, of which 82 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Enzymatic Esterase--oxidase, Cholesterol, Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes, Colorimetry, Cholinesterase, Catalytic Methods, Amylase, Diazo Colorimetry, Bilirubin . Use the specialty filter in the sidebar to narrow results.

82 devices
1–25 of 82
ELISA CMV IGM
K914789 · LKQ Antibody Igm,if,... · Microbiology
Mar 1992 133d
ELISA TOXO IGM
K914852 · LGD Enzyme Linked... · Microbiology
Jan 1992 87d
ELISA RUBELLA IGM
K914420 · LFX Enzyme Linked... · Microbiology
Dec 1991 85d
NORMAL AND ABNORMAL CONTROL SERA
K895943 · JJY Multi-analyte Controls,... · Chemistry
Dec 1989 77d
TOTAL BILIRUBIN L.F.
K895822 · CIG Diazo Colorimetry, Bilirubin · Chemistry
Nov 1989 46d
CREATININE 340 (ENZYMATIC)
K895847 · CGX Alkaline Picrate,... · Chemistry
Oct 1989 27d
ATYPICAL CHOLINESTERASE
K873496 · DIH Colorimetry, Cholinesterase · Chemistry
Jan 1989 528d
CHOLINESTERASE - BUTYRYTHIOCHOLINE SUBSTRATE
K880049 · DIH Colorimetry, Cholinesterase · Chemistry
Jan 1989 387d
CHOLINESTERASE - ACETYTHIOCHOLINE SUBSTRATE
K880199 · DIH Colorimetry, Cholinesterase · Chemistry
Jan 1989 380d
SAITRON 430 RANDOM ACCESS CHEMISTRY ANALYZER
K884035 · JJE Analyzer, Chemistry... · Chemistry
Dec 1988 97d
TOTAL IRON BINDING CAPACITY TEST
K884649 · JQE Resin, Ion-exchange,... · Chemistry
Dec 1988 37d
UNIFAST ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST
K882325 · GFO Activated Partial... · Hematology
Aug 1988 80d
REAGENTS FOR TSH ASSAY
K881381 · JLW Radioimmunoassay,... · Chemistry
Jul 1988 111d
IMMPULSE T, ASSAY REAGENTS
K881214 · CDP Radioimmunoassay, Total... · Toxicology
May 1988 67d
IRON TEST
K881202 · JIY Photometric Method, Iron... · Chemistry
Apr 1988 38d
ACP KINETIC TEST (ACID PHOSPHATASE TEST)
K881204 · CKB Acid Phosphatase,... · Chemistry
Apr 1988 38d
MODIFIED CRP LATEX TEST
K880016 · DCK C-reactive Protein,... · Immunology
Feb 1988 51d
IMMPULSE DIGOXIN ASSAY REAGENTS
K874748 · LCS Radioimmunoassay, Digoxin... · Toxicology
Feb 1988 93d
IMMPULSE T4 ASSAY REAGENTS
K875081 · CDX Radioimmunoassay, Total... · Toxicology
Feb 1988 64d
DIFFERENTIAL I.M. SCREENING TEST
K873297 · KTN System, Test, Infectious... · Immunology
Dec 1987 118d
REUMA TEST
K873782 · DHR System, Test, Rheumatoid... · Immunology
Nov 1987 72d
ALBUMIN SCREEN TEST
K870516 · JIQ Turbidimetric Method,... · Chemistry
Oct 1987 258d
BNP-AMYLASE TEST
K873133 · JFJ Catalytic Methods, Amylase · Chemistry
Oct 1987 57d
UNIFAST CK-MB
K873134 · CGS Nad Reduction/nadh... · Chemistry
Sep 1987 37d
DIAGNOSTIC KIT FREE T3 AND FREE T4
K870268 · CEC Radioimmunoassay, Free... · Chemistry
Sep 1987 234d

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