FDA Product Code
FDA Product Code LSR — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Microbiology
- 21 CFR Citation
- 866.3830
510(k) Clearances — 112 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K885290 | BORRELIA BURGDORFERI POLYVALENT IGG/IGM ANTIBODY | Medical Diagnostic Technologies, Inc. | 1989-04-10 | Traditional | PDF ↗ |
| K885294 | BORRELIA BURGDORFERI IGM ANTIBODY TEST SYSTEM | Medical Diagnostic Technologies, Inc. | 1989-04-10 | Traditional | PDF ↗ |
| K885293 | BORRELIA BURGDORFERI IGG ANTIBODY TEST SYSTEM | Medical Diagnostic Technologies, Inc. | 1989-04-10 | Traditional | PDF ↗ |
| K890281 | HUMAN LYME EIA FOR THE DETECT OF ANTIBODIES | Cambridge Bioscience Corp. | 1989-03-15 | Traditional | PDF ↗ |
| K883767 | LYME DISEASE IFA (IGM) | Hillcrest Biologicals | 1989-03-15 | Traditional | PDF ↗ |
| K885317 | LYME ELISA TEST SYSTEM | Zeus Scientific, Inc. | 1989-03-02 | Traditional | PDF ↗ |
| K883544 | LYME FAST TEST | 3M Company | 1989-01-13 | Traditional | PDF ↗ |
| K883487 | LYME DISEASE IFA (IGG) | Hillcrest Biologicals | 1988-12-13 | Traditional | PDF ↗ |
| K880476 | LYME DISEASE ELISA | Hillcrest Biologicals | 1988-04-26 | Traditional | PDF ↗ |
| K875286 | LYME STAT TEST KIT | Whittaker Bioproducts, Inc. | 1988-03-30 | Traditional | PDF ↗ |
| K872247 | FIAX TEST KIT FOR LYME DISEASE ANTIBODIES | Whittaker Bioproducts, Inc. | 1987-10-15 | Traditional | PDF ↗ |
| K871246 | IFA TEST FOR ANTIBODIES TO BORRELIA BURGDORFERI | Zeus Scientific, Inc. | 1987-08-25 | Traditional | PDF ↗ |
Product code LSR · Class II · Microbiology. Data: openFDA.