Product code GWC
- Device name
- Antisera, All Types, Streptococcus Pneumoniae
- Medical specialty
- Microbiology
- Device class
- 1
- Regulation number
- 866.3740
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 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 |
| K862848 | LKB ULTROBACT (TM) PNEUMOCOCCUS KIT; 2321-110 | Lkb Instruments, Inc. | 1986-12-18 |
| 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 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05713106105573 | ImmuView S. pneumoniae and L. pneumophila urinary antigen test | Ssi Diagnostica A/S | 2022-10-25 |
| 05713106768693 | Pneumococcus Type 20 serum high titer, 1 mL | Ssi Diagnostica A/S | 2021-08-01 |
| 05713106769232 | Pneumococcus Factor 19b serum high titer, 1 mL | Ssi Diagnostica A/S | 2021-08-01 |
| 05713106769218 | Pneumococcus Factor 9e serum high titer, 1 mL | Ssi Diagnostica A/S | 2021-08-01 |
| 05713106769201 | Pneumococcus Factor 9d serum high titer, 1 mL | Ssi Diagnostica A/S | 2021-08-01 |
| 05713106769188 | Pneumococcus Factor 7b serum high titer, 1 mL | Ssi Diagnostica A/S | 2021-08-01 |
| 05713106769171 | Pneumococcus Factor 6b serum high titer, 1 mL | Ssi Diagnostica A/S | 2021-08-01 |
| 05713106769164 | Pneumococcus Group 33 serum high titer, 1 mL | Ssi Diagnostica A/S | 2021-08-01 |
| 05713106769157 | Pneumococcus Group 18 serum high titer, 1 mL | Ssi Diagnostica A/S | 2021-08-01 |
| 05713106769140 | Pneumococcus Group 17 serum high titer, 1 mL | Ssi Diagnostica A/S | 2021-08-01 |
| 05713106769133 | Pneumococcus Group 15 serum high titer, 1 mL | Ssi Diagnostica A/S | 2021-08-01 |
| 05713106769119 | Pneumococcus Group 12 serum high titer, 1 mL | Ssi Diagnostica A/S | 2021-08-01 |
| 05713106768822 | Pneumococcus Group 11 serum high titer, 1 mL | Ssi Diagnostica A/S | 2021-08-01 |
| 05713106768778 | Pneumococcus Group 10 serum high titer, 1 mL | Ssi Diagnostica A/S | 2021-08-01 |
| 05713106768730 | Pneumococcus Group 7 serum high titer, 1 mL | Ssi Diagnostica A/S | 2021-08-01 |
| 05713106768716 | Pneumococcus Group 6 serum high titer, 1 mL | Ssi Diagnostica A/S | 2021-08-01 |
| 05713106768679 | Pneumococcus Type 14 serum high titer, 1 mL | Ssi Diagnostica A/S | 2021-08-01 |
| 05713106768662 | Pneumococcus Type 8 serum high titer, 1 mL | Ssi Diagnostica A/S | 2021-08-01 |
| 05713106768648 | Pneumococcus Type 5 serum high titer, 1 mL | Ssi Diagnostica A/S | 2021-08-01 |
| 05713106768594 | Pneumococcus Type 4 serum high titer, 1 mL | Ssi Diagnostica A/S | 2021-08-01 |
| 05713106768587 | Pneumococcus Type 3 serum high titer, 1 mL | Ssi Diagnostica A/S | 2021-08-01 |
| 05713106768563 | Pneumococcus Type 2 serum high titer, 1 mL | Ssi Diagnostica A/S | 2021-08-01 |
| 05713106768549 | Pneumococcus Type 1 serum high titer, 1 mL | Ssi Diagnostica A/S | 2021-08-01 |
| 05713106732663 | Pneumococcus Factor 6d serum, 1 mL | Ssi Diagnostica A/S | 2021-08-01 |
| 05713106732656 | ImmuLex Streptococcus Group Kit, 6 x 1.5 mL | Ssi Diagnostica A/S | 2021-08-01 |
| 05713106663981 | ImmuLex S. pneumoniae Type 4, 1.5 mL | Ssi Diagnostica A/S | 2021-08-01 |
| 05713106549919 | ImmuLex Strep-B kit, 10 x 1.5 mL | Ssi Diagnostica A/S | 2021-08-01 |
| 05713106024515 | ImmuView S. pneumoniae and L. pneumophila urinary antigen test | Ssi Diagnostica A/S | 2020-03-24 |
| 04931921007693 | Nihon Kohden, EEG-1200A Series Neurofax | NIHON KOHDEN CORPORATION | 2019-07-24 |
| 00841983100857 | NA | NIHON KOHDEN AMERICA, INC. | 2016-09-19 |