FDA Product Code
FDA Product Code LJM — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5100
510(k) Clearances — 112 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K870455 | SM EIA DIAGNOSTIC KIT | Biohytech International, Inc. | 1987-03-17 | Traditional | PDF ↗ |
| K870457 | RNP EIA DIAGNOSTIC KIT | Biohytech International, Inc. | 1987-03-17 | Traditional | PDF ↗ |
| K862969 | ANA-ENZYME IMMUNOASSAY (ANA-EIA) DIAGNOSTIC KIT | Biohytech International, Inc. | 1986-10-24 | Traditional | PDF ↗ |
| K852840 | ENZYME ANTINUCLEAR ANTIBODY SCREENING TEST | Modern Diagnostics, Inc. | 1985-08-01 | Traditional | PDF ↗ |
| K852230 | ANA/LITE-RL TEST SYSTEM | Immuno-Products Industries | 1985-07-10 | Traditional | PDF ↗ |
| K852231 | ANA/LITE-HEP-2 TEST SYSTEM | Immuno-Products Industries | 1985-07-10 | Traditional | PDF ↗ |
| K843904 | DNA STAT TEST KIT | Whittaker Bioproducts, Inc. | 1984-11-01 | Traditional | PDF ↗ |
| K843745 | ADP ANA APPLEZYME | Apple Diagnostic Products | 1984-10-25 | Traditional | PDF ↗ |
| K842533 | AMIZYME-ANDNA TEST KIT | Amico Lab, Inc. | 1984-09-20 | Traditional | PDF ↗ |
| K842532 | AMIZYME-ANA TEST KIT | Amico Lab, Inc. | 1984-09-20 | Traditional | PDF ↗ |
| K833148 | ENZYME ANA TEST SYSTEM | Immuno Concepts, Inc. | 1983-11-21 | Traditional | PDF ↗ |
| K822346 | HISTIMUNE ENZYME-ANA TEST | Icl Scientific | 1982-10-08 | Traditional | PDF ↗ |
Product code LJM · Class II · Immunology. Data: openFDA.