FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Biological Stains
CFR Sub-Part
Subpart C—Cell And Tissue Culture Products
CFR Sub-Part
KIP
Formulations, Balanced Salt Solutions
1
Product Code
KIQ
Kit, Culture, Chromosome
1
Product Code
KIR
Cells, Animal And Human, Cultured
1
Product Code
KIS
Sera, Animal And Human
1
Product Code
K
88
1287
ANIMAL AND HUMAN SERA
1
Cleared 510(K)
K
88
0471
BOVINE CALF SERUM SUPPLEMENTED #A-2159
1
Cleared 510(K)
K
88
0470
BOVINE CALF SERUM CATALOG #A-2119
1
Cleared 510(K)
K
87
2847
SOLCOSERYL TISSUE CULTURE GROWTH SUPPLEMENT
1
Cleared 510(K)
K
87
0580
MLC NORMAL SERUM
1
Cleared 510(K)
K
87
0938
FETAL BOVINE SERUM
1
Cleared 510(K)
K
87
0469
DEFINED EQUINE SERUM #A-3311
1
Cleared 510(K)
K
87
0468
ADULT BOVINE SERUM
1
Cleared 510(K)
K
87
0467
DEFINED CALF BOVINE SERUM SUPPLEMENTED #A-2151
1
Cleared 510(K)
K
87
0466
DEFINED CALF BOVINE SERUM #A-2111
1
Cleared 510(K)
Show All 45 Submissions
KIT
Media And Components, Synthetic Cell And Tissue Culture
1
Product Code
KIW
Kit, Mycoplasma Detection
1
Product Code
KIX
Media, Mycoplasma Detection
1
Product Code
KIY
Chamber, Slide Culture
1
Product Code
KIZ
Dish, Tissue Culture
1
Product Code
KJA
Flask, Tissue Culture
1
Product Code
KJB
Apparatus, Roller
1
Product Code
KJC
Bottle, Roller, Tissue Culture
1
Product Code
KJD
Spinner, Flask
1
Product Code
KJE
Spinner System, Cell Culture
1
Product Code
KJF
System, Suspension, Cell Culture
1
Product Code
KJH
Apparatus, Perfusion
1
Product Code
KPB
Media And Components, Mycoplasma Detection
1
Product Code
Subpart D—Pathology Instrumentation and Accessories
CFR Sub-Part
Subpart E—Immunology Laboratory Equipment and Reagents
CFR Sub-Part
Subpart E—Specimen Preparation Reagents
CFR Sub-Part
Subpart F—Automated and Semi-Automated Hematology Devices
CFR Sub-Part
Subpart F—Immunological Test Systems
CFR Sub-Part
Subpart G—Tumor Associated Antigen immunological Test Systems
CFR Sub-Part
Subpart H—Hematology Kits and Packages
CFR Sub-Part
Subpart J—Products Used In Establishments That Manufacture Blood and Blood Products
CFR Sub-Part
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 9 May 2025 at 11:05 pm
PA
/
subpart-c—cell-and-tissue-culture-products
/
KIS
/
K870466
View Source
DEFINED CALF BOVINE SERUM #A-2111
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K870466
510(k) Type
Traditional
Applicant
HYCLONE LABORATORIES, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/24/1987
Days to Decision
49 days
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Miscellaneous
Subpart B—Biological Stains
Subpart C—Cell And Tissue Culture Products
KIP
Formulations, Balanced Salt Solutions
KIQ
Kit, Culture, Chromosome
KIR
Cells, Animal And Human, Cultured
KIS
Sera, Animal And Human
K
88
1287
ANIMAL AND HUMAN SERA
K
88
0471
BOVINE CALF SERUM SUPPLEMENTED #A-2159
K
88
0470
BOVINE CALF SERUM CATALOG #A-2119
K
87
2847
SOLCOSERYL TISSUE CULTURE GROWTH SUPPLEMENT
K
87
0580
MLC NORMAL SERUM
K
87
0938
FETAL BOVINE SERUM
K
87
0469
DEFINED EQUINE SERUM #A-3311
K
87
0468
ADULT BOVINE SERUM
K
87
0467
DEFINED CALF BOVINE SERUM SUPPLEMENTED #A-2151
K
87
0466
DEFINED CALF BOVINE SERUM #A-2111
Show All 45 Submissions
KIT
Media And Components, Synthetic Cell And Tissue Culture
KIW
Kit, Mycoplasma Detection
KIX
Media, Mycoplasma Detection
KIY
Chamber, Slide Culture
KIZ
Dish, Tissue Culture
KJA
Flask, Tissue Culture
KJB
Apparatus, Roller
KJC
Bottle, Roller, Tissue Culture
KJD
Spinner, Flask
KJE
Spinner System, Cell Culture
KJF
System, Suspension, Cell Culture
KJH
Apparatus, Perfusion
KPB
Media And Components, Mycoplasma Detection
Subpart D—Pathology Instrumentation and Accessories
Subpart E—Immunology Laboratory Equipment and Reagents
Subpart E—Specimen Preparation Reagents
Subpart F—Automated and Semi-Automated Hematology Devices
Subpart F—Immunological Test Systems
Subpart G—Tumor Associated Antigen immunological Test Systems
Subpart H—Hematology Kits and Packages
Subpart J—Products Used In Establishments That Manufacture Blood and Blood Products
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
PA
/
subpart-c—cell-and-tissue-culture-products
/
KIS
/
K870466
View Source
DEFINED CALF BOVINE SERUM #A-2111
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K870466
510(k) Type
Traditional
Applicant
HYCLONE LABORATORIES, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/24/1987
Days to Decision
49 days