LKB ULTROBACT (TM) PNEUMOCOCCUS KIT; 2321-110
FDA 510(k) clearance K862848 · decided 1986-12-18
Clearance details
- K-number
- K862848
- Device name
- LKB ULTROBACT (TM) PNEUMOCOCCUS KIT; 2321-110
- Applicant
- Lkb Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-07-29
- Decision date
- 1986-12-18
- Days to decision
- 142 days
- Clearance type
- Traditional
- Product code
- GWC
- Device class
- 1
- Regulation number
- 866.3740
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Gaithersburg, MD, 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 |
| IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAE (K870029) | American Micro Scan | 1987-03-25 |
| 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.