IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAE
FDA 510(k) clearance K870029 · decided 1987-03-25
Clearance details
- K-number
- K870029
- Device name
- IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAE
- Applicant
- American Micro Scan
- Decision
- Substantially Equivalent
- Date received
- 1987-01-05
- Decision date
- 1987-03-25
- Days to decision
- 79 days
- Clearance type
- Traditional
- Product code
- GWC
- Device class
- 1
- Regulation number
- 866.3740
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- West 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) S. PNEUMONIAE (K884966) | Armkel, LLC | 1989-02-07 |
| BACTIGEN(R) MENINGITIDIS PANEL (K884965) | Armkel, LLC | 1989-02-07 |
| LKB ULTROBACT (TM) PNEUMOCOCCUS KIT; 2321-110 (K862848) | Lkb Instruments, Inc. | 1986-12-18 |
| VENTRESCREEN STREP A TEST (K842239) | Ventrex Laboratories, Inc. | 1984-07-02 |
| WELLCOGEN S. PNEUMONIAE (K841376) | Wellcome Diagnostics | 1984-05-02 |
| BACTIGEN S. PNEUMONIAE (K831887) | Armkel, LLC | 1983-09-26 |
| BBL PNEUMOSLIDE TEST (K821960) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1982-07-30 |
| PHADEBACT PNEUMOCOCCUS TEST (K802337) | Pharmacia, Inc. | 1980-10-31 |
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 |