QUANTUM II YEAST IDENT. SYSTEM
FDA 510(k) clearance K832406 · decided 1983-09-26
Clearance details
- K-number
- K832406
- Device name
- QUANTUM II YEAST IDENT. SYSTEM
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1983-07-21
- Decision date
- 1983-09-26
- Days to decision
- 67 days
- Clearance type
- Traditional
- Product code
- JXC
- Device class
- 1
- Regulation number
- 866.2660
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Abbott Park, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Abbott Laboratories
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CHROMAGAR CANDIDA (K960075) | Hardy Diagnostics | 1996-08-02 |
| ALBICANS SURE (K913426) | Jrga Diagnostics | 1992-04-22 |
| GERM TUBE SOLUTION (K884720) | Remel Co. | 1989-06-02 |
| C. ALBICANS SCREEN (K891476) | Carr-Scarborough Microbiologicals, Inc. | 1989-04-12 |
| SOC SLIDE CULTURE SYSTEM (K882371) | The Cancer Center AT Wadley Institutes | 1988-07-18 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| 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 |
| ARCHITECT Total PSA / Alinity i Total PSA (P910007/S066) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT Free PSA / Alinity i Free PSA (P980007/S055) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S052) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N (P210003/S013) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S012) | Abbott Laboratories | 2024-09-30 |