FDA Product Code
FDA Product Code LGO — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.7675
510(k) Clearances — 5 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K894947 | PLATELIA TOXO IGG KIT | Kallestad Diag, A Div. of Erbamont, Inc. | 1990-03-23 | Traditional | PDF ↗ |
| K874544 | SNAP(R) CAMPYLOBACTER CULTURE IDENT DIAGNOSTIC KIT | Molecular Biosystems, Inc. | 1988-08-12 | Traditional | PDF ↗ |
| K791118 | HLA CONTROL SERA | Calbiochem-Behring Corp. | 1979-08-03 | Traditional | PDF ↗ |
| K761008 | LYMPHOCYTE TYPING, NEGATIVE CONTROL | Hyland Therapeutic Div., Travenol Laboratories | 1977-04-06 | Traditional | PDF ↗ |
| K761009 | LYMPHOCYTE TYPING, POSITIVE CONTROL | Hyland Therapeutic Div., Travenol Laboratories | 1977-04-06 | Traditional | PDF ↗ |
Product code LGO · Class I · Hematology. Data: openFDA.