510(k) K821960
- Device
- BBL PNEUMOSLIDE TEST
- Applicant
- BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
- 510(k) number
- K821960
- Product code
- GWC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-07-30
- Date received
- 1982-07-01
- 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#
- Address
- 1875 Eye St. NW Suite 625 Washington DC US 20006 20006
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 |
| 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 |
| K802337 | PHADEBACT PNEUMOCOCCUS TEST | Pharmacia, Inc. | 1980-10-31 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases