Product code DBL— Immunology
AFT SYSTEM PROFICIENCY TESTING PROGRAM
- Classification name
- Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
- Device class
- Class 2
- Regulation
- 21 CFR 866.5660
- Advisory panel
- Immunology
- Total cleared
- 24
- First cleared
- Most recent
Market context for product code DBL
FDA has cleared devices under product code DBL between 1980 and 2018, filed by 19 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2018
- 1998
- 1997
- 1996
- 1995
- 1994
- 1993
- 1991
- 1990
- 1989
- 1988
- 1987
- 1982
- 1981
- 1980
Top applicants under product code DBL
Recent clearances under product code DBL
- K180202 — Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts
- K980312 — NOVA LITE ENDOMYSIAL
- K974169 — WIELISA ANTI-GBM TEST SYSTEM
- K971464 — IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT
- K971658 — MOUSE LIVER KIDNEY STOMACH DIAGNOSTIC TEST KIT
- K963525 — DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT
- K955431 — RIT LIVER, KIDNEY, STOMACH IFA KIT
- K953495 — EIA KIT FOR THE DETECTION OF GBM ANTIBODIES
- K944191 — ANTI-NUCLEAR ANTIBODY(ANA) TEST KIT W/MOUSE LIVER
- K944192 — ANTI-NUCLEAR ANTIBODY (ANA) TEST KIT W/RAT LIVER
- K913360 — ANTI-RETICULIN ANTIBODY (ARA) TEST
- K912551 — ANTI-ENDOMYSIAL ANTIBODY TEST
- K904181 — ANTI-GBM ANTIBODIES QUANTITATIVE KIT
- K902237 — MEDICA IIF ANTI-SKIN ANTIBODY TEST KIT
- K891098 — ANTI-SKIN ANTIBODY TEST(MONKEY ESOPHAGUS SECTIONS)
- K891099 — ANTI-SKIN ANTIBODY TEST(MONKEY/GUIN PIG ESOPH SEC)
- K883915 — AUTOANTIBODY TEST SYSTEM (MOUSE KIDNEY/STOMACH)
- K871194 — I-125 ANTI-MICROSOMAL ANTIBODY IRMA TEST KIT
- K821576 — ANTINUCLEAR ANTIBODY SCREEN FLOURESC
- K820088 — AFT SYSTEM PROFICIENCY TESTING PROGRAM
- K811261 — ANTI-SKIN ANTIBODY TEST SYSTEM
- K801960 — ANTI-DS/N-DNA TEST KIT
- K792610 — KALLESTAD FLORESCENT ANA/AMA/ASMA TEST
- K791996 — MULTIPLE AUTO ANTIBODY TEST
Data sourced from openFDA. This site is unofficial and independent of the FDA.