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Subpart B—Cardiovascular Diagnostic Devices
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart C—General Hospital and Personal Use Monitoring Devices
CFR Sub-Part
Subpart D—Pathology Instrumentation and Accessories
CFR Sub-Part
FMH
Container, Specimen, Sterile
1
Product Code
K
90
0983
TRI-TECH URINE SPECIMEN KIT
1
Cleared 510(K)
K
82
3763
VARIOUS-SPECIMEN COLLECTORS
1
Cleared 510(K)
K
82
0180
CALCULI FILTER CUP
1
Cleared 510(K)
K
81
2933
LANCER SPECIMEN CONTAINER
1
Cleared 510(K)
K
80
2340
SPECIMEN SET
1
Cleared 510(K)
K
80
2002
URINE SPECIMEN CONTAINER #'S 1013-1016
1
Cleared 510(K)
K
80
0947
MIDSTREAM COLLECTION KIT
1
Cleared 510(K)
K
80
0309
SPECIMEN COLLECTION PAN
1
Cleared 510(K)
K
80
0233
ABCO MIDSTREAM URINE COLLECTION SET
1
Cleared 510(K)
K
79
2710
PARA-PAK CLEAN VIAL
1
Cleared 510(K)
Show All 23 Submissions
NNI
Container, Specimen, Non-Sterile
1
Product Code
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
Subpart F—Neurological Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—General Hospital and Personal Use Miscellaneous Devices
CFR Sub-Part
Subpart G—Miscellaneous Devices
CFR Sub-Part
Hematology
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Immunology
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Microbiology
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Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
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Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 20 June 2025 at 11:06 pm
HO
/
subpart-d—pathology-instrumentation-and-accessories
/
FMH
/
K823763
View Source
VARIOUS-SPECIMEN COLLECTORS
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K823763
510(k) Type
Traditional
Applicant
CORDIS CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/19/1983
Days to Decision
36 days
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
Subpart B—Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart C—General Hospital and Personal Use Monitoring Devices
Subpart D—Pathology Instrumentation and Accessories
FMH
Container, Specimen, Sterile
K
90
0983
TRI-TECH URINE SPECIMEN KIT
K
82
3763
VARIOUS-SPECIMEN COLLECTORS
K
82
0180
CALCULI FILTER CUP
K
81
2933
LANCER SPECIMEN CONTAINER
K
80
2340
SPECIMEN SET
K
80
2002
URINE SPECIMEN CONTAINER #'S 1013-1016
K
80
0947
MIDSTREAM COLLECTION KIT
K
80
0309
SPECIMEN COLLECTION PAN
K
80
0233
ABCO MIDSTREAM URINE COLLECTION SET
K
79
2710
PARA-PAK CLEAN VIAL
Show All 23 Submissions
NNI
Container, Specimen, Non-Sterile
Subpart D—Prosthetic Devices
Subpart E—Surgical Devices
Subpart F—General Hospital and Personal Use Therapeutic Devices
Subpart F—Neurological Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Subpart G—General Hospital and Personal Use Miscellaneous Devices
Subpart G—Miscellaneous Devices
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
HO
/
subpart-d—pathology-instrumentation-and-accessories
/
FMH
/
K823763
View Source
VARIOUS-SPECIMEN COLLECTORS
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K823763
510(k) Type
Traditional
Applicant
CORDIS CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/19/1983
Days to Decision
36 days