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Miscellaneous
Subpart B—Biological Stains
CFR Sub-Part
Subpart C—Cell And Tissue Culture Products
CFR Sub-Part
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
GIA
Test, Leukocyte Peroxidase
1
Product Code
K
93
1241
FAST'N'FLAMMATORY KIT
1
Cleared 510(K)
K
84
4402
SIGMA PEROXIDASE MYELOPEROXIDASE STAINING PROCEDUR
1
Cleared 510(K)
K
81
1011
HISTOCHEMICAL DEMONSTRATION OF LEUKOCYTE
1
Cleared 510(K)
NPQ
Test, Factor V Leiden Mutations, Genomic Dna Pcr
2
Product Code
NPR
Test, Factor Ii G20210a Mutations, Genomic Dna Pcr
2
Product Code
PHJ
System, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophilia Related Mutations
2
Product Code
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 25 January 2026 at 3:41 am
PA
/
subpart-h—hematology-kits-and-packages
/
GIA
/
K931241
View Source
FAST'N'FLAMMATORY KIT
Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
PDF
Analyzed PDF
510(k) Number
K931241
510(k) Type
Traditional
Applicant
TECHLAB, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/3/1994
Days to Decision
329 days
Submission Type
Summary
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
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
GIA
Test, Leukocyte Peroxidase
K
93
1241
FAST'N'FLAMMATORY KIT
K
84
4402
SIGMA PEROXIDASE MYELOPEROXIDASE STAINING PROCEDUR
K
81
1011
HISTOCHEMICAL DEMONSTRATION OF LEUKOCYTE
NPQ
Test, Factor V Leiden Mutations, Genomic Dna Pcr
NPR
Test, Factor Ii G20210a Mutations, Genomic Dna Pcr
PHJ
System, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophilia Related Mutations
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-h—hematology-kits-and-packages
/
GIA
/
K931241
View Source
FAST'N'FLAMMATORY KIT
Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
PDF
Analyzed PDF
510(k) Number
K931241
510(k) Type
Traditional
Applicant
TECHLAB, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/3/1994
Days to Decision
329 days
Submission Type
Summary