IMMUNOSCAN DIRECT HEMOPHILUS INFLUENZAE TYPE B TES
FDA 510(k) clearance K854490 · decided 1985-12-27
Clearance details
- K-number
- K854490
- Device name
- IMMUNOSCAN DIRECT HEMOPHILUS INFLUENZAE TYPE B TES
- Applicant
- American Micro Scan
- Decision
- Substantially Equivalent
- Date received
- 1985-11-12
- Decision date
- 1985-12-27
- Days to decision
- 45 days
- Clearance type
- Traditional
- Product code
- GRP
- Device class
- 2
- Regulation number
- 866.3300
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Sacramento, CA, 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 |
|---|---|---|
| BACTIGEN(R) H. INFLUENZAE TYPE B (K884967) | Armkel, LLC | 1989-02-07 |
| H-FLU B ELISA TEST (K831525) | Seragen Diagnostics, Inc. | 1983-09-29 |
| H. INFLUENZA B ANTISERA FOR CIE (K823348) | Diagnostica, Inc. | 1982-12-28 |
| BBL DIRECTIGEN MENINGITIS TEST KIT (K821266) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1982-06-01 |
| HAEMOPHILUS INFLUENZAE TYPE B ANTISERUM (K820192) | Hyland Therapeutic Div., Travenol Laboratories | 1982-03-11 |
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 |