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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
K
87
0491
KREBS-RINGER BICARBONATE BUFFER PRODUCT NO. K4002
1
Cleared 510(K)
K
87
0486
EARLE'S BALANCED SALTS (EBSS) HYBRI-MAX #E9509
1
Cleared 510(K)
K
87
0484
HANKS' BALANCED SALTS (HBSS) NO. H1387
1
Cleared 510(K)
K
87
0482
(D-PBS) MODIFIED HYBRI-MAX PRODUCT NO. D7030
1
Cleared 510(K)
K
86
0784
DULBECCO'S PHOSPHATE BUFFERED SALINE W/CALCL2
1
Cleared 510(K)
K
84
4878
TRYPSIN 10X - 1:250 IN HBSS W/O CA & MG
1
Cleared 510(K)
K
84
4877
HEPES BUFFER IM IN NORMAL SALINE
1
Cleared 510(K)
K
84
2725
SALINE, 0.85%W/PRESERVATIVE
1
Cleared 510(K)
K
84
2724
SALINE 0.85% W/O PRESERVATIVE
1
Cleared 510(K)
K
84
2723
SALINE, 1.3% W/O PRESERVATIVE
1
Cleared 510(K)
Show All 17 Submissions
KIQ
Kit, Culture, Chromosome
1
Product Code
KIR
Cells, Animal And Human, Cultured
1
Product Code
KIS
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1
Product Code
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
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Subpart F—Immunological Test Systems
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Subpart G—Tumor Associated Antigen immunological Test Systems
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Physical Medicine
Review Panel
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Review Panel
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Review Panel
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Review Panel
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Review Panel
Unknown
Review Panel
Last synced on 23 May 2025 at 11:06 pm
PA
/
subpart-c—cell-and-tissue-culture-products
/
KIP
/
K870491
View Source
KREBS-RINGER BICARBONATE BUFFER PRODUCT NO. K4002
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K870491
510(k) Type
Traditional
Applicant
SIGMA CHEMICAL CO.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/30/1987
Days to Decision
55 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
K
87
0491
KREBS-RINGER BICARBONATE BUFFER PRODUCT NO. K4002
K
87
0486
EARLE'S BALANCED SALTS (EBSS) HYBRI-MAX #E9509
K
87
0484
HANKS' BALANCED SALTS (HBSS) NO. H1387
K
87
0482
(D-PBS) MODIFIED HYBRI-MAX PRODUCT NO. D7030
K
86
0784
DULBECCO'S PHOSPHATE BUFFERED SALINE W/CALCL2
K
84
4878
TRYPSIN 10X - 1:250 IN HBSS W/O CA & MG
K
84
4877
HEPES BUFFER IM IN NORMAL SALINE
K
84
2725
SALINE, 0.85%W/PRESERVATIVE
K
84
2724
SALINE 0.85% W/O PRESERVATIVE
K
84
2723
SALINE, 1.3% W/O PRESERVATIVE
Show All 17 Submissions
KIQ
Kit, Culture, Chromosome
KIR
Cells, Animal And Human, Cultured
KIS
Sera, Animal And Human
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
/
KIP
/
K870491
View Source
KREBS-RINGER BICARBONATE BUFFER PRODUCT NO. K4002
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K870491
510(k) Type
Traditional
Applicant
SIGMA CHEMICAL CO.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/30/1987
Days to Decision
55 days