NEG COMBO BREAKPOINT PANEL POS COMBO
FDA 510(k) clearance K854278 · decided 1986-03-04
Clearance details
- K-number
- K854278
- Device name
- NEG COMBO BREAKPOINT PANEL POS COMBO
- Applicant
- American Micro Scan
- Decision
- Substantially Equivalent
- Date received
- 1985-10-24
- Decision date
- 1986-03-04
- Days to decision
- 131 days
- Clearance type
- Traditional
- Product code
- JWX
- Device class
- 1
- Regulation number
- 866.2660
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Sacramento, CA, US
- Third-party review
- No
- Expedited review
- No
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| SLIDEX STAPH-KIT (K923212) | Biomerieux Vitek, Inc. | 1992-09-28 |
| VISI-STAPH (K905617) | Connecticut Diagnostics, Ltd. | 1991-03-29 |
| AXIOM TOTAL KNEE SYSTEM, TIBIAL COMPONENT (K902259) | Orthomet, Inc. | 1990-06-18 |
| STAPHSLIDE (K874019) | Ncs Diagnostics, Inc. | 1987-10-28 |
| V-TREND KIT STAPH LATEX TEST (K855220) | Texas Immunology, Inc. | 1986-03-03 |
| RAPI - STAPH (K852997) | Advanced Medical Technology, Inc. | 1985-08-19 |
| BACTO STAPHYLOCOCCUS LATEX TEST (K843560) | Difco Laboratories, Inc. | 1984-10-01 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| MIC PANELS (N62160/S013) | American Micro Scan | 1985-03-05 |
| MIC PANELS (N62160/S011) | American Micro Scan | 1984-01-30 |
| MIC PANELS (N62160/S012) | American Micro Scan | 1984-01-30 |
| MIC PANELS (N62160/S010) | American Micro Scan | 1983-10-12 |
| MIC PANELS (N62160/S009) | American Micro Scan | 1983-09-28 |
| MIC PANELS (N62160/S008) | American Micro Scan | 1983-08-10 |
| MIC PANELS (N62160/S007) | American Micro Scan | 1983-02-03 |
| MIC PANELS (N62160/S006) | American Micro Scan | 1982-11-18 |