510(k) K862848
- Device
- LKB ULTROBACT (TM) PNEUMOCOCCUS KIT; 2321-110
- Applicant
- LKB INSTRUMENTS, INC.
- 510(k) number
- K862848
- Product code
- GWC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-12-18
- Date received
- 1986-07-29
- Regulation
- 866.3740
- Classification name
- Antisera, All Types, Streptococcus Pneumoniae
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ED ZIOR
- Address
- 9319 Gaither Rd. Gaithersburg MD US 20877 20877
FDA Registration Numbers#
- 3003750284
- 9611882
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GWC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K884965 | BACTIGEN(R) MENINGITIDIS PANEL | Armkel, LLC | 1989-02-07 |
| K884966 | BACTIGEN(R) S. PNEUMONIAE | Armkel, LLC | 1989-02-07 |
| K870029 | IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAE | American Micro Scan | 1987-03-25 |
| K842239 | VENTRESCREEN STREP A TEST | Ventrex Laboratories, Inc. | 1984-07-02 |
| K841376 | WELLCOGEN S. PNEUMONIAE | Wellcome Diagnostics | 1984-05-02 |
| K831887 | BACTIGEN S. PNEUMONIAE | Armkel, LLC | 1983-09-26 |
| K821960 | BBL PNEUMOSLIDE TEST | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1982-07-30 |
| K802337 | PHADEBACT PNEUMOCOCCUS TEST | Pharmacia, Inc. | 1980-10-31 |
Legacy Summary#
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FDA Review#
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