BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD FACSuite Clinical Software, BD Multitest 6-Color Assays, BD Multitest 4-Color Assays, BD Multitest 6-Color TBNK
K170974 is the FDA 510(k) clearance record for BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD FACSuite Clinical Software, BD Multitest 6-Color Assays, BD Multitest 4-Color Assays, BD Multitest 6-Color TBNK, a class II device, cleared for Becton, Dickinson and Company on under FDA product code OYE (Flow Cytometric Reagents And Accessories.). FDA's definition for product code OYE reads: "To identify and classify cells or other particles in suspension by their inherent physical properties or associated fluorescent molecules in order to provide information about the distribution or number cells in suspension or their level...". FDA records list 345 510(k) clearances for Becton, Dickinson and Company, from to . As of , FDA records show 17 recalls naming K170974.
Clearance record
- Decision date
- Received
- (91 days to decision)
- Product code
- OYE Flow Cytometric Reagents And Accessories.
- Regulation
- 21 CFR 864.5220
- Device class
- Class II
- Review panel
- Hematology
- Applicant
- Becton, Dickinson and Company 2350 Qume Dr., San Jose CA
- 510(k) summary
- Summary PDF
- Third party review
- No
Clearances, product code OYE
Trailing 12 monthsFDA records hold no clearances under product code OYE in the trailing twelve months.
Show the numbers
| Month | Clearances |
|---|---|
| November 2025 | 0 |
| December 2025 | 0 |
| January 2026 | 0 |
| February 2026 | 0 |
| March 2026 | 0 |
| April 2026 | 0 |
| May 2026 | 0 |
| June 2026 | 0 |
| July 2026 | 0 |
| August 2026 | 0 |
| September 2026 | 0 |
| October 2026 | 0 |
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