510(k) K840507
- Device
- NEISSERIA MENINGITIDIS GR. Y
- Applicant
- SCIENTIFIC DEVICE LABORATORY, INC.
- 510(k) number
- K840507
- Product code
- LSC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-03-23
- Date received
- 1984-02-06
- Regulation
- 866.2660
- Classification name
- Neisseria Controls
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LSC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K840506 | HAEMOPHILUS INFLUENZAE TYPE B | Scientific Device Laboratory, Inc. | 1984-04-04 |
| K840504 | SDL NEISSERIA MENINGITIDES GR. 2 | Scientific Device Laboratory, Inc. | 1984-03-23 |
| K840505 | SDL NEISSERIA MENNINGITIDIS GR. X | Scientific Device Laboratory, Inc. | 1984-03-23 |
| K840509 | NEISSERIA MENINGITIDIS GR. B | Scientific Device Laboratory, Inc. | 1984-03-23 |
| K840510 | NEISSERIA MENINGITIDIS GR. A | Scientific Device Laboratory, Inc. | 1984-03-23 |
| K840514 | NEISSERIA MENINGITIDIS CONTROL | Scientific Device Laboratory, Inc. | 1984-03-23 |
Legacy Summary#
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FDA Review#
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