Agglutinating Serum W135
FDA 510(k) K771562 · Burroughs Wellcome Co.
510(k) numberK771562
Submission
- Device name
- Agglutinating Serum W135
- Applicant
- Burroughs Wellcome Co.
Mchenry, IL, US - Received
- August 15, 1977
- Decision date
- August 25, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GTJ – Antisera, All Groups, N. Meningitidis
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3390
- Specialty
- Microbiology
Other 510(k)s with product code GTJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K952791 | Directigen Meningitis Combo TestGTJ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 05/30/1996SE |
| K915330 | Directigen Meningitis Combo Test KitGTJ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 03/23/1992SE |
| K910210 | Slidex Meningite-Kit 5GTJ · Traditional | Vitek Systems, Inc. | 08/12/1991SE |
| K885004 | Bactigen(R) N. MeningitidisGTJ · Traditional | Armkel, LLC | 02/07/1989SE |
| K870089 | Immunoscan(Tm) Direct Neisseria Meningitidis KitGTJ · Traditional | Microscan Div. Baxter Healthcare Corp. | 03/17/1987SE |
| K854852 | Wellcogen Bacterial Antigen KitGTJ · Traditional | Wellcome Diagnostics | 02/04/1986SE |
| K854851 | Wellcogen N. Meningitidis B/E. Coli K1 ZL24GTJ · Traditional | Wellcome Diagnostics | 02/04/1986SE |
| K844999 | Phadebact CSF TestGTJ · Traditional | Pharmacia, Inc. | 10/17/1985SE |
| K851691 | Willcogen Meningitidis Kit ZL25GTJ · Traditional | Wellcome Diagnostics | 06/10/1985SE |
| K844762 | Meningococcus Group B Monoclonal Antibody ZM-51GTJ · Traditional | Wellcome Diagnostics | 06/04/1985SE |
More from Wellcome Diagnostics
| 510(k) | Device | Decision |
|---|---|---|
| K820069 | Wellcogen Group BGTZ · Traditional | 02/18/1982SE |
| K813508 | Sac-CelKTS · Traditional | 12/29/1981SE |
| K810215 | Dac-Cel HCGJHI · Traditional | 04/17/1981SE |
| K810214 | Dac-Cel DiagnatalJHI · Traditional | 03/06/1981SE |
| K810213 | Dac-Cel TSHJLW · Traditional | 02/10/1981SE |
| K810212 | Dac-Cel T3 UptakeKHQ · Traditional | 02/10/1981SE |
| K791232 | Dac-Cel T3CDP · Traditional | 09/04/1979SE |
| K791231 | Dac-Cel T4CDX · Traditional | 09/04/1979SE |
| K781607 | Strep-TexGTZ · Traditional | 10/17/1978SE |
| K780874 | Thymune-TDDC · Traditional | 06/14/1978SE |
Questions and answers
When was Agglutinating Serum W135 cleared by the FDA?
Agglutinating Serum W135 (K771562) received a 510(k) decision of Substantially Equivalent on August 25, 1977, 10 days after the submission was received.
What is the product code of K771562?
The FDA product code is GTJ – Antisera, All Groups, N. Meningitidis, a Class II (moderate risk) device regulated under 21 CFR 866.3390.