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
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- DIIColumns, Glc1Product Code
- DJAColumn Supports, Glc1Product Code
- DJOIndicator, Cellulose Fluorescent, Tlc1Product Code
- DJSU.V. Light, Tlc1Product Code
- DJYIon-Exchange Chromatography1Product Code
- DKGPlate, Cellulose, Tlc1Product Code
- DKKTanks, Developing, Tlc1Product Code
- DKOAdsorbents, Ion-Exchange1Product Code
- DKSPlate, Silica Gel, Tlc1Product Code
- DKYIndicator, Alumina Fluorescent, Tlc1Product Code
- DLCAtomizer, Tlc1Product Code
- DLGCoating, Liquid, Glc1Product Code
- DLOIndicator, Silica Gel Fluorescent, Tlc1Product Code
- DLYPlate, Alumina, Tlc1Product Code
- DMGPapers, Ion1Product Code
- DMSGases, Glc1Product Code
- DMZLiquid Chromatography, Adsorbent1Product Code
- DNHResins, Ion-Exchange, Liquid Chromatography1Product Code
- DOPMass Spectrometer, Clinical Use1Product Code
- DPAApparatus, General Use, Thin Layer Chromatography1Product Code
- DPMColumns, Liquid Chromatography1Product Code
- JSQChromatography For Bacterial Identification1Product Code
- JXQMonitor, U.V., Glc1Product Code
- JXRAtomic Absorption Spectrophotometer, General Use1Product Code
- KEAResins, Ion-Exchange1Product Code
- KIEApparatus, High Pressure Liquid Chromatography1Product Code
- KZQChromatography(Gas), Clinical Use1Product Code
- KZRChromatography (Liquid, Gel), Clinical Use1Product Code
- KZSChromatography (Thin Layer), Clinical Use1Product Code
- LDMInstrumentation, High Pressure Liquid Chromatography1Product Code
- K960392CDM1Cleared 510(K)
- K961557ALLIANCE 2690 SEPARATIONS MODULE1Cleared 510(K)
- K942451BIO-RAD CLINICAL DATA MANAGEMENT SYSTEM1Cleared 510(K)
- K922388WATERS(TM) LC MODULE I FOR CLINICAL USE1Cleared 510(K)
- K920136WATERS 717 AUTOSAMPLER1Cleared 510(K)
- K903647MODULE 486 VARIABLE WAVELENGTH TUNABLE UV/VIS DETE1Cleared 510(K)
- K884886MODEL 250 LIQUID CHROMOTAGRAPHY PUMP1Cleared 510(K)
- K872582HIGH PRESSURE LIQUID CHROMATOGRAPHY SYSTEM1Cleared 510(K)
- K870949WATERS 650 ADVANCED PROTEIN PURIFICATION SYSTEM1Cleared 510(K)
- K862178ISOPURE LC SYSTEM1Cleared 510(K)
Show All 19 Submissions
- LEQDetectors, Electrochemical, Liquid Chromatography1Product Code
- PFFHigh Throughput Dna Sequence Analyzer2Product Code
- Subpart D—Clinical Toxicology Test SystemsCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
- Subpart G—Manual Hematology DevicesCFR Sub-Part
- Subpart H—Hematology Kits and PackagesCFR Sub-Part
- Medical GeneticsReview Panel
- UnknownReview Panel
BIO-RAD CLINICAL DATA MANAGEMENT SYSTEM
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K942451
- 510(k) Type
- Traditional
- Applicant
- BIO-RAD
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/10/1994
- Days to Decision
- 171 days
- Submission Type
- Statement