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Subpart B—Biological Stains
CFR Sub-Part
GJH
Stain, Reticulocyte
1
Product Code
K
79
0042
STAIN, HEMASTAIN RETIC
1
Cleared 510(K)
GJJ
Stains, Heinz Body
1
Product Code
GJL
Romanowsky Stains
1
Product Code
Subpart B—Diagnostic Devices
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CFR Sub-Part
Subpart H—Hematology Kits and Packages
CFR Sub-Part
Subpart I—Hematology Reagents
CFR Sub-Part
Subpart J—Products Used In Establishments That Manufacture Blood and Blood Products
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Subpart K—Products Used In Establishments That Manufacture Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
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Last synced on 9 May 2025 at 11:05 pm
HE
/
subpart-b—biological-stains
/
GJH
/
K790042
View Source
STAIN, HEMASTAIN RETIC
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K790042
510(k) Type
Traditional
Applicant
GEOMETRIC DATA, DIV. SMITHKLINE CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/15/1979
Days to Decision
41 days
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Miscellaneous
Subpart B—Biological Stains
GJH
Stain, Reticulocyte
K
79
0042
STAIN, HEMASTAIN RETIC
GJJ
Stains, Heinz Body
GJL
Romanowsky Stains
Subpart B—Diagnostic Devices
Subpart C—Cell And Tissue Culture Products
Subpart C—Clinical Laboratory Instruments
Subpart E—Specimen Preparation Reagents
Subpart F—Automated and Semi-Automated Hematology Devices
Subpart F—General Hospital and Personal Use Therapeutic Devices
Subpart F—Immunological Test Systems
Subpart G—Manual Hematology Devices
Subpart G—Tumor Associated Antigen immunological Test Systems
Subpart H—Hematology Kits and Packages
Subpart I—Hematology Reagents
Subpart J—Products Used In Establishments That Manufacture Blood and Blood Products
Subpart K—Products Used In Establishments That Manufacture Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
HE
/
subpart-b—biological-stains
/
GJH
/
K790042
View Source
STAIN, HEMASTAIN RETIC
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K790042
510(k) Type
Traditional
Applicant
GEOMETRIC DATA, DIV. SMITHKLINE CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/15/1979
Days to Decision
41 days