FDA Product Code
FDA Product Code DBL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5660
510(k) Clearances — 24 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K180202 | Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts | Immuno Concepts, N.A. , Ltd. | 2018-10-19 | Traditional | PDF ↗ |
| K980312 | NOVA LITE ENDOMYSIAL | Inova Diagnostics, Inc. | 1998-04-02 | Traditional | PDF ↗ |
| K974169 | WIELISA ANTI-GBM TEST SYSTEM | Wieslab AB | 1998-02-17 | Traditional | PDF ↗ |
| K971464 | IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT | Euro-Diagnostica AB | 1997-10-29 | Traditional | PDF ↗ |
| K971658 | MOUSE LIVER KIDNEY STOMACH DIAGNOSTIC TEST KIT | Jay H. Geller | 1997-05-23 | Traditional | PDF ↗ |
| K963525 | DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT | Shield Diagnostics, Ltd. | 1996-11-07 | Traditional | PDF ↗ |
| K955431 | RIT LIVER, KIDNEY, STOMACH IFA KIT | The Binding Site, Ltd. | 1996-04-23 | Traditional | PDF ↗ |
| K953495 | EIA KIT FOR THE DETECTION OF GBM ANTIBODIES | Scimedx Corp. | 1996-04-10 | Traditional | PDF ↗ |
| K944192 | ANTI-NUCLEAR ANTIBODY (ANA) TEST KIT W/RAT LIVER | Light Diagnostics | 1995-03-06 | Traditional | PDF ↗ |
| K944191 | ANTI-NUCLEAR ANTIBODY(ANA) TEST KIT W/MOUSE LIVER | Light Diagnostics | 1995-03-06 | Traditional | PDF ↗ |
| K913360 | ANTI-RETICULIN ANTIBODY (ARA) TEST | Immco Diagnostics, Inc. | 1994-09-26 | Traditional | PDF ↗ |
| K912551 | ANTI-ENDOMYSIAL ANTIBODY TEST | Immco Diagnostics, Inc. | 1993-06-09 | Traditional | PDF ↗ |
| K904181 | ANTI-GBM ANTIBODIES QUANTITATIVE KIT | Biochemical Diagnostic, Inc. | 1991-09-10 | Traditional | PDF ↗ |
| K902237 | MEDICA IIF ANTI-SKIN ANTIBODY TEST KIT | Medica Corp. | 1990-07-09 | Traditional | PDF ↗ |
| K891099 | ANTI-SKIN ANTIBODY TEST(MONKEY/GUIN PIG ESOPH SEC) | Immco Diagnostics, Inc. | 1989-03-22 | Traditional | PDF ↗ |
| K891098 | ANTI-SKIN ANTIBODY TEST(MONKEY ESOPHAGUS SECTIONS) | Immco Diagnostics, Inc. | 1989-03-22 | Traditional | PDF ↗ |
| K883915 | AUTOANTIBODY TEST SYSTEM (MOUSE KIDNEY/STOMACH) | Immco Diagnostics, Inc. | 1988-10-19 | Traditional | PDF ↗ |
| K871194 | I-125 ANTI-MICROSOMAL ANTIBODY IRMA TEST KIT | Cronus | 1987-04-20 | Traditional | PDF ↗ |
| K821576 | ANTINUCLEAR ANTIBODY SCREEN FLOURESC | Immuno-Products Industries | 1982-06-10 | Traditional | PDF ↗ |
| K820088 | AFT SYSTEM PROFICIENCY TESTING PROGRAM | Calbiochem-Behring Corp. | 1982-01-26 | Traditional | PDF ↗ |
| K811261 | ANTI-SKIN ANTIBODY TEST SYSTEM | Zeus Scientific, Inc. | 1981-08-12 | Traditional | PDF ↗ |
| K801960 | ANTI-DS/N-DNA TEST KIT | Immuno-Diagnostic Products, Inc. | 1980-10-10 | Traditional | PDF ↗ |
| K792610 | KALLESTAD FLORESCENT ANA/AMA/ASMA TEST | Kallestad Laboratories, Inc. | 1980-02-22 | Traditional | PDF ↗ |
| K791996 | MULTIPLE AUTO ANTIBODY TEST | Meda Stat Diagnostics, Inc. | 1980-01-16 | Traditional | PDF ↗ |
Product code DBL · Class II · Immunology. Data: openFDA.