FDA Product Code
FDA Product Code KSG — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.9600
510(k) Clearances — 13 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K812565 | ELUTION SOLUTION | Biological Corp. of America | 1981-10-23 | Traditional | PDF ↗ |
| K812222 | EM-X | Biological Corp. of America | 1981-09-23 | Traditional | PDF ↗ |
| K800943 | PENTEX BOVINE ALBUMIN 30% SOLUTION | Miles Laboratories, Inc. | 1980-05-08 | Traditional | PDF ↗ |
| K800189 | BOVINE ALBUMIN 22% & 30% SOLUTIONS | Gotham Biologics, Inc. | 1980-02-13 | Traditional | PDF ↗ |
| K791791 | ORTHO ANTIBODY ENHANCEMENT SOLUTION | Ortho Diagnostics, Inc. | 1979-10-11 | Traditional | PDF ↗ |
| K791113 | LOW IONIC STRENGTH SOLUTION (LISS) | Hyland Therapeutic Div., Travenol Laboratories | 1979-06-28 | Traditional | PDF ↗ |
| K790973 | LO-ION | Gamma Biologicals, Inc. | 1979-06-15 | Traditional | PDF ↗ |
| K790776 | DADE LOW IONIC STRENGTH SOLUITION (LISS) | Dade, Baxter Travenol Diagnostics, Inc. | 1979-05-23 | Traditional | PDF ↗ |
| K790498 | LISS REAGENT | Fisher Scientific Co., LLC | 1979-04-03 | Traditional | PDF ↗ |
| K781435 | ORTHO LOW IONIC SOLUTION | Ortho Diagnostics, Inc. | 1978-09-14 | Traditional | PDF ↗ |
| K781397 | EM-V | Biological Corp. of America | 1978-09-14 | Traditional | PDF ↗ |
| K780556 | SPECT RIM (LISS) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-04-24 | Traditional | PDF ↗ |
| K780413 | LOW IIONIC STRENGTH SOLUTION | Pfizer, Inc. | 1978-04-24 | Traditional | PDF ↗ |
Product code KSG · Class II · Hematology. Data: openFDA.