FOLATE/B12 DUO-BEAD RADIOASSAY
FDA 510(k) clearance K822241 · decided 1982-10-26
Clearance details
- K-number
- K822241
- Device name
- FOLATE/B12 DUO-BEAD RADIOASSAY
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1982-07-27
- Decision date
- 1982-10-26
- Days to decision
- 91 days
- Clearance type
- Traditional
- Product code
- CEN
- Device class
- 1
- Regulation number
- 862.1550
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Abbott Park, IL, US
- Third-party review
- No
- Expedited review
- No
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| FEMEXAM TESTCARD (K962718) | Litmus Concepts, Inc. | 1997-02-07 |
| KYOTEST 5V (K840827) | Kyoto Diagnostics, Inc. | 1984-05-14 |
| URINE SCREENING KIT (K830824) | Syn-Kit, Inc. | 1983-06-12 |
| HELENA BIOSTRIP PH (K830979) | Helena Laboratories | 1983-05-05 |
| LITH A TEST TM (K830091) | Lenal Creative Approaches, Inc. | 1983-02-15 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ARCHITECT AFP; Alinity i AFP (LN 3P36/07P90) (P120008/S032) | Abbott Laboratories | 2026-05-11 |
| ARCHITECT Total PSA / Alinity i Total PSA (LN 6C06/07P92) (P910007/S068) | Abbott Laboratories | 2026-02-23 |
| ARCHITECT Free PSA; Alinity i Free PSA (LN 6C07/07P93) (P980007/S056) | Abbott Laboratories | 2026-02-12 |
| ARCHITECT Total PSA; Alinity i Total PSA (LN 6C06/07P92) (P910007/S067) | Abbott Laboratories | 2026-02-12 |
| ARCHITECT AFP; Alinity i AFP (LN 3P36/07P90) (P120008/S031) | Abbott Laboratories | 2026-02-12 |
| ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT AFP / Alinity i AFP (P120008/S030) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043) | Abbott Laboratories | 2025-04-03 |