Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
- Subpart C—Cell And Tissue Culture ProductsCFR Sub-Part
- KIPFormulations, Balanced Salt Solutions1Product Code
- KIQKit, Culture, Chromosome1Product Code
- KIRCells, Animal And Human, Cultured1Product Code
- KISSera, Animal And Human1Product Code
- K881287ANIMAL AND HUMAN SERA1Cleared 510(K)
- K880471BOVINE CALF SERUM SUPPLEMENTED #A-21591Cleared 510(K)
- K880470BOVINE CALF SERUM CATALOG #A-21191Cleared 510(K)
- K872847SOLCOSERYL TISSUE CULTURE GROWTH SUPPLEMENT1Cleared 510(K)
- K870580MLC NORMAL SERUM1Cleared 510(K)
- K870938FETAL BOVINE SERUM1Cleared 510(K)
- K870469DEFINED EQUINE SERUM #A-33111Cleared 510(K)
- K870468ADULT BOVINE SERUM1Cleared 510(K)
- K870467DEFINED CALF BOVINE SERUM SUPPLEMENTED #A-21511Cleared 510(K)
- K870466DEFINED CALF BOVINE SERUM #A-21111Cleared 510(K)
- K870466DEFINED CALF BOVINE SERUM #A-21111Cleared 510(K)
- K870463DEFINED FETAL BOVINE SERUM #A-11111Cleared 510(K)
- K870467DEFINED CALF BOVINE SERUM SUPPLEMENTED #A-21511Cleared 510(K)
- K861813HUMAN AB SERUM - STERILE FILTERED1Cleared 510(K)
- K861815BOVINE BLOOD CELLS IN ALSEVERS CITRATE/DEFIBRINATE1Cleared 510(K)
- K861809LAMB SERUM - STERILE FILTERED1Cleared 510(K)
- K861810CHICKEN SERUM - STERILE FILTERED1Cleared 510(K)
- K861811MOUSE SERUM - STERILE FILTERED1Cleared 510(K)
- K861812HUMAN SERUM - STERILE FILTERED1Cleared 510(K)
- K861814RHESUS MONKEY SERUM - STERILE FILTERED1Cleared 510(K)
- K861816MOUSE BLOOD CELLS IN ALSEVERS OR CITRATE1Cleared 510(K)
- K861817HORSE BLOOD CELLS IN ALSEVERS CITRATE/DEFIBRINATED1Cleared 510(K)
- K860752GOAT SERUM (29-391-54)1Cleared 510(K)
- K860762GAMMA-FREE HORSE SERUM1Cleared 510(K)
- K853803FETAL BOVINE/FETAL CALF SERUM, NEWBORN, HORSE, RAB1Cleared 510(K)
- K843629FETAL BOVINE SERUM, F4884 STERILE GROWT1Cleared 510(K)
- K833463CLEX1Cleared 510(K)
- K812385NATAL CALF (BOVINE) SERUM - STERILE1Cleared 510(K)
- K812384NEWBORN CALF SERUM - STERILE1Cleared 510(K)
- K812381DONOR HORSE SERUM - STERILE1Cleared 510(K)
- K812382DONOR CALF (BOVINE-SERUM) - STERILE1Cleared 510(K)
- K812386FETAL BOVINE SERUM - STERILE1Cleared 510(K)
- K812383CALF (BOVINE) SERUM - STERILE1Cleared 510(K)
- K812379GUINEA PIG SERUM - STERILE1Cleared 510(K)
- K812380RABBIT SERUM - STERILE1Cleared 510(K)
- K812329ZETA-SERA D1Cleared 510(K)
- K810775GOAT SERUM-STERILE1Cleared 510(K)
- K810874FETAL CALF SERUM1Cleared 510(K)
- K810904BOVINE CALF SERUM1Cleared 510(K)
- K810903NEWBORN BOVINE SERUM1Cleared 510(K)
- K810478ANIMAL SERUM PRODUCTS1Cleared 510(K)
- K810268NORMLCERA1Cleared 510(K)
- K802418FETAL BOVINE SERUM1Cleared 510(K)
- K800781FETAL BOVINE SERUM1Cleared 510(K)
- K780009GUINEA PIG WHOLE SERUM1Cleared 510(K)
- KITMedia And Components, Synthetic Cell And Tissue Culture1Product Code
- KIWKit, Mycoplasma Detection1Product Code
- KIXMedia, Mycoplasma Detection1Product Code
- KIYChamber, Slide Culture1Product Code
- KIZDish, Tissue Culture1Product Code
- KJAFlask, Tissue Culture1Product Code
- KJBApparatus, Roller1Product Code
- KJCBottle, Roller, Tissue Culture1Product Code
- KJDSpinner, Flask1Product Code
- KJESpinner System, Cell Culture1Product Code
- KJFSystem, Suspension, Cell Culture1Product Code
- KJHApparatus, Perfusion1Product Code
- KPBMedia And Components, Mycoplasma Detection1Product Code
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart E—Immunology Laboratory Equipment and ReagentsCFR Sub-Part
- Subpart E—Specimen Preparation ReagentsCFR Sub-Part
- Subpart F—Automated and Semi-Automated Hematology DevicesCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
- Subpart G—Tumor Associated Antigen immunological Test SystemsCFR Sub-Part
- Subpart H—Hematology Kits and PackagesCFR Sub-Part
- Subpart J—Products Used In Establishments That Manufacture Blood and Blood ProductsCFR Sub-Part
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
ZETA-SERA D
- Page Type
- Cleared 510(K)
- 510(k) Number
- K812329
- 510(k) Type
- Traditional
- Applicant
- AMF BIOLOGICAL AND DIAGNOSTICS CO.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/1/1981
- Days to Decision
- 14 days