OLYMPUS APOLIPOPROTEIN B IMMUNOTURBIDIMETRIC REAGENT
FDA 510(k) clearance K952466 · decided 1995-06-05
Clearance details
- K-number
- K952466
- Device name
- OLYMPUS APOLIPOPROTEIN B IMMUNOTURBIDIMETRIC REAGENT
- Applicant
- Olympus America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-05-26
- Decision date
- 1995-06-05
- Days to decision
- 10 days
- Clearance type
- Traditional
- Product code
- JHN
- Device class
- 1
- Regulation number
- 862.1475
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Melville, NY, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| APOLIPOPROTEIN A-I IMMUNOTURBIDIMETRIC KIT (K950383) | Randox Laboratories, Ltd. | 1995-09-15 |
| APOLIPOPROTEIN B IMMUNOTURBIDIEMETRIC KIT (K950382) | Randox Laboratories, Ltd. | 1995-09-15 |
| WAKO AUTOKIT APO A1 (K952615) | Wako Chemicals USA, Inc. | 1995-09-08 |
| OLYMPUS APOLIPOPROTEIN A1 IMMUNOTURBIDIMETRIC REAGENT (K952425) | Olympus America, Inc. | 1995-07-05 |
| APOLIPOPROTIEN B (APO B) (K932603) | Sigma Diagnostics, Inc. | 1994-06-02 |
| APOLIPOPROTIEN A-1 (APO A-1) (K932606) | Sigma Diagnostics, Inc. | 1994-06-02 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Apo B Reagent, REF: OSR6143 recall (Z-1815-2025) | Beckman Coulter Ireland, Inc. | 2025-05-23 |