MS-2 IDENTIFICATION SYSTEM
FDA 510(k) clearance K802309 · decided 1980-12-01
Clearance details
- K-number
- K802309
- Device name
- MS-2 IDENTIFICATION SYSTEM
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1980-09-23
- Decision date
- 1980-12-01
- Days to decision
- 69 days
- Clearance type
- Traditional
- Product code
- JXB
- 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
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| C. ALBICANS PNA FISH (K062461) | Advandx, Inc. | 2006-10-25 |
| YEASTEST (K993554) | Diagnostic Markers, Inc. | 2000-02-10 |
| RAPID YEAST PLUS SYSTEM (K943621) | Innovative Diagnostic Systems, Inc. | 1995-01-27 |
| BACTICARD CANDIDA (K935124) | Remel Co. | 1994-02-25 |
| MICRORING YT (K900112) | Medical Wire & Equipment Co. | 1990-07-31 |
| VITEK YEAST BIOCHEMICAL CARD (K881925) | Vitek Systems, Inc. | 1988-06-16 |
| YEAST IDENTIFICATION PANEL (K860575) | American Micro Scan | 1986-05-13 |
| YEAST IDENT (K830286) | Analytical Products, Inc. | 1983-04-05 |
| NITRATE SWAB-RAPID TEST (K800803) | Remel Co. | 1980-07-08 |
| CAPIK-CANDIDA ALBICANS IDENT. KIT. (K800908) | Immuno-Mycologics, Inc. | 1980-06-02 |
| AMS YEAST BIOCHEMICAL CARD (K792231) | Vitek Systems, Inc. | 1979-12-19 |
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 |