Anesthesiology
Review Panel
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- MiscellaneousMiscellaneous
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart C—Microbiology DevicesCFR Sub-Part
- Subpart D—Clinical Toxicology Test SystemsCFR Sub-Part
- Subpart D—Serological ReagentsCFR Sub-Part
- Subpart E—Immunology Laboratory Equipment and ReagentsCFR Sub-Part
- JZSElectrophoresis Instrumentation1Product Code
- JZTFluorometer1Product Code
- K962499ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READER1Cleared 510(K)
- K883349QLIA IMMUNOCHEMISTRY SYSTEM1Cleared 510(K)
- K882677STAT-20 FLUOROMETER1Cleared 510(K)
- K864699FLUORESCENCE CONCENTRATION ANALYZER (FCA)1Cleared 510(K)
- K863434THE FIAX 5000 FLUOROMETER1Cleared 510(K)
- K862674PHOTON ELITE/AUTOMATED RANDOM ACCESS IM/CH SYSTEM1Cleared 510(K)
- K852240SMS, SCREEN MACHINE SYSTEM1Cleared 510(K)
- K842049FLUOROSKAN1Cleared 510(K)
- K843356FIAX 100 FLUOROMETER1Cleared 510(K)
- K834070IMMPULSE SYSTEM1Cleared 510(K)
Show All 14 Submissions
- JZWNephelometer1Product Code
- DHLProtein, Complement, Antigen, Antiserum, Control1Product Code
- JZPPlates, Ouchterlony Agar1Product Code
- JZQPlates And Equipment, Radial Immunodiffusion1Product Code
- JZRSupport Gels1Product Code
- JZXEquipment, Rocket Immunoelectrophoresis1Product Code
- KTQReagent, Complement1Product Code
- PIVAutomated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use2Product Code
- 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
- MicrobiologyReview Panel
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- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
FLUORESCENCE CONCENTRATION ANALYZER (FCA)
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K864699
- 510(k) Type
- Traditional
- Applicant
- PANDEX LABORATORIES, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/22/1986
- Days to Decision
- 20 days