DBL — Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control Class II
FDA product code DBL covers "Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control", a Class II medical device regulated under 21 CFR 866.5660. Submissions are reviewed by the Immunology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DBL
- Device Class
- Class II
- Regulation Number
- 866.5660
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K180202 | immuno concepts, n.a. | Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immun | October 19, 2018 |
| K980312 | inova diagnostics | NOVA LITE ENDOMYSIAL | April 2, 1998 |
| K974169 | wieslab | WIELISA ANTI-GBM TEST SYSTEM | February 17, 1998 |
| K971464 | euro-diagnostica | IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT | October 29, 1997 |
| K971658 | jay h. geller | MOUSE LIVER KIDNEY STOMACH DIAGNOSTIC TEST KIT | May 23, 1997 |
| K963525 | shield diagnostics | DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT | November 7, 1996 |
| K955431 | binding site | RIT LIVER, KIDNEY, STOMACH IFA KIT | April 23, 1996 |
| K953495 | scimedx | EIA KIT FOR THE DETECTION OF GBM ANTIBODIES | April 10, 1996 |
| K944192 | light diagnostics | ANTI-NUCLEAR ANTIBODY (ANA) TEST KIT W/RAT LIVER | March 6, 1995 |
| K944191 | light diagnostics | ANTI-NUCLEAR ANTIBODY(ANA) TEST KIT W/MOUSE LIVER | March 6, 1995 |
| K913360 | immco diagnostics | ANTI-RETICULIN ANTIBODY (ARA) TEST | September 26, 1994 |
| K912551 | immco diagnostics | ANTI-ENDOMYSIAL ANTIBODY TEST | June 9, 1993 |
| K904181 | biochemical diagnostic | ANTI-GBM ANTIBODIES QUANTITATIVE KIT | September 10, 1991 |
| K902237 | medica | MEDICA IIF ANTI-SKIN ANTIBODY TEST KIT | July 9, 1990 |
| K891098 | immco diagnostics | ANTI-SKIN ANTIBODY TEST(MONKEY ESOPHAGUS SECTIONS) | March 22, 1989 |
| K891099 | immco diagnostics | ANTI-SKIN ANTIBODY TEST(MONKEY/GUIN PIG ESOPH SEC) | March 22, 1989 |
| K883915 | immco diagnostics | AUTOANTIBODY TEST SYSTEM (MOUSE KIDNEY/STOMACH) | October 19, 1988 |
| K871194 | cronus | I-125 ANTI-MICROSOMAL ANTIBODY IRMA TEST KIT | April 20, 1987 |
| K821576 | immuno-products industries | ANTINUCLEAR ANTIBODY SCREEN FLOURESC | June 10, 1982 |
| K820088 | calbiochem-behring | AFT SYSTEM PROFICIENCY TESTING PROGRAM | January 26, 1982 |