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Biological Sterilization Process Indicator With Recombinant-Dna Plasmid
2
Product Code
K
18
1442
VERIFY Assert Self-Contained Biological Indicator
2
Cleared 510(K)
Show All 5 Submissions
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Last synced on 25 January 2026 at 3:41 am
HO
/
HO-misc
/
OWP
/
K181442
View Source
VERIFY Assert Self-Contained Biological Indicator
Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
PDF
Analyzed PDF
510(k) Number
K181442
510(k) Type
Special
Applicant
Steris Corporation
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/13/2018
Days to Decision
12 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Miscellaneous
OWP
Biological Sterilization Process Indicator With Recombinant-Dna Plasmid
K
18
1442
VERIFY Assert Self-Contained Biological Indicator
Show All 5 Submissions
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
HO
/
HO-misc
/
OWP
/
K181442
View Source
VERIFY Assert Self-Contained Biological Indicator
Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
PDF
Analyzed PDF
510(k) Number
K181442
510(k) Type
Special
Applicant
Steris Corporation
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/13/2018
Days to Decision
12 days
Submission Type
Summary