NEISSERIA MENINGITIDIS GR. A
FDA 510(k) clearance K840510 · decided 1984-03-23
Clearance details
- K-number
- K840510
- Device name
- NEISSERIA MENINGITIDIS GR. A
- Applicant
- Scientific Device Laboratory, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-02-06
- Decision date
- 1984-03-23
- Days to decision
- 46 days
- Clearance type
- Traditional
- Product code
- LSC
- Device class
- 1
- Regulation number
- 866.2660
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Mchenry, IL, 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 |
|---|---|---|
| HAEMOPHILUS INFLUENZAE TYPE B (K840506) | Scientific Device Laboratory, Inc. | 1984-04-04 |
| NEISSERIA MENINGITIDIS GR. B (K840509) | Scientific Device Laboratory, Inc. | 1984-03-23 |
| SDL NEISSERIA MENNINGITIDIS GR. X (K840505) | Scientific Device Laboratory, Inc. | 1984-03-23 |
| SDL NEISSERIA MENINGITIDES GR. 2 (K840504) | Scientific Device Laboratory, Inc. | 1984-03-23 |
| NEISSERIA MENINGITIDIS GR. Y (K840507) | Scientific Device Laboratory, Inc. | 1984-03-23 |
| NEISSERIA MENINGITIDIS CONTROL (K840514) | Scientific Device Laboratory, Inc. | 1984-03-23 |
Recalls involving this device
No recalls on record reference this clearance.