BBL Pneumoslide Test
FDA 510(k) K821960 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK821960
Submission
- Device name
- BBL Pneumoslide Test
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Washington, DC, US - Received
- July 1, 1982
- Decision date
- July 30, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GWC – Antisera, All Types, Streptococcus Pneumoniae
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3740
- Specialty
- Microbiology
Other 510(k)s with product code GWC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K884966 | Bactigen(R) S. PneumoniaeGWC · Traditional | Armkel, LLC | 02/07/1989SE |
| K884965 | Bactigen(R) Meningitidis PanelGWC · Traditional | Armkel, LLC | 02/07/1989SE |
| K870029 | Immunoscan(Tm) Direct Streptococcus PneumoniaeGWC · Traditional | American Micro Scan | 03/25/1987SE |
| K862848 | LKB Ultrobact (TM) Pneumococcus Kit; 2321-110GWC · Traditional | Lkb Instruments, Inc. | 12/18/1986SE |
| K842239 | Ventrescreen Strep a TestGWC · Traditional | Ventrex Laboratories, Inc. | 07/02/1984SE |
| K841376 | Wellcogen S. PneumoniaeGWC · Traditional | Wellcome Diagnostics | 05/02/1984SE |
| K831887 | Bactigen S. PneumoniaeGWC · Traditional | Armkel, LLC | 09/26/1983SE |
| K802337 | Phadebact Pneumococcus TestGWC · Traditional | Pharmacia, Inc. | 10/31/1980SE |
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| K003062 | Bactec Mgit 960 Sir KitsMJA · Traditional | 06/06/2001SE |
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| K003461 | BD Vacutainer Passive Shielding Blood Collection NeedleFMI · Traditional | 02/01/2001SE |
| K002938 | B-D Ultra-Fine III Pen Needle; Model 31G X 3/16FMI · Traditional | 11/29/2000SE |
| K001364 | BD Directigen Flu A+BPSZ · Traditional | 06/28/2000SE |
| K000762 | Moxifloxacin, 5 Ug, BBL Sensi-DiscJTN · Traditional | 04/25/2000SE |
| K000829 | Gatifloxacin, 5 Ug, BBL Sensi-DiscJTN · Traditional | 04/13/2000SE |
| K993186 | Synercid, 15 Ug, BBL Sensi-DiscJTN · Traditional | 11/03/1999SE |
| K992734 | Becton Dickinson SyringeMEG · Traditional | 10/01/1999SE |
| K992849 | QBC Star Centrifugal Hematology SystemGKZ · Special | 09/23/1999SE |
Questions and answers
When was BBL Pneumoslide Test cleared by the FDA?
BBL Pneumoslide Test (K821960) received a 510(k) decision of Substantially Equivalent on July 30, 1982, 29 days after the submission was received.
What is the product code of K821960?
The FDA product code is GWC – Antisera, All Types, Streptococcus Pneumoniae, a Class I (low risk) device regulated under 21 CFR 866.3740.