KSG
13 FDA 510(k) clearances · Product code
29 daysmedian time to decision
44 days90th percentile
13clearances measured
FDA profile
- Official device name
- Media, Potentiating For In Vitro Diagnostic Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.9600
- Medical specialty
- Hematology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ELUTION SOLUTION (K812565) | Biological Corp. of America | 1981-10-23 |
| EM-X (K812222) | Biological Corp. of America | 1981-09-23 |
| PENTEX BOVINE ALBUMIN 30% SOLUTION (K800943) | Miles Laboratories, Inc. | 1980-05-08 |
| BOVINE ALBUMIN 22% & 30% SOLUTIONS (K800189) | Gotham Biologics, Inc. | 1980-02-13 |
| ORTHO ANTIBODY ENHANCEMENT SOLUTION (K791791) | Ortho Diagnostics, Inc. | 1979-10-11 |
| LOW IONIC STRENGTH SOLUTION (LISS) (K791113) | Hyland Therapeutic Div., Travenol Laboratories | 1979-06-28 |
| LO-ION (K790973) | Gamma Biologicals, Inc. | 1979-06-15 |
| DADE LOW IONIC STRENGTH SOLUITION (LISS) (K790776) | Dade, Baxter Travenol Diagnostics, Inc. | 1979-05-23 |
| LISS REAGENT (K790498) | Fisher Scientific Co., LLC | 1979-04-03 |
| ORTHO LOW IONIC SOLUTION (K781435) | Ortho Diagnostics, Inc. | 1978-09-14 |
| EM-V (K781397) | Biological Corp. of America | 1978-09-14 |
| LOW IIONIC STRENGTH SOLUTION (K780413) | Pfizer, Inc. | 1978-04-24 |
| SPECT RIM (LISS) (K780556) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-04-24 |
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Every clearance here is in the API, with alerts when new ones post.