Mycoplasma Pneumoniae CF Antigen
FDA 510(k) K834338 · Hillcrest Biologicals
510(k) numberK834338
Submission
- Device name
- Mycoplasma Pneumoniae CF Antigen
- Applicant
- Hillcrest Biologicals
Walker, MI, US - Received
- December 12, 1983
- Decision date
- February 27, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GSB – Antigens, Cf, All, Mycoplasma Spp.
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3375
- Specialty
- Microbiology
Other 510(k)s with product code GSB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K852933 | Mycoplasma SPP Serological ReagentsGSB · Traditional | Microbix Biosystems, Inc. | 08/01/1985SE |
| K843664 | Mycoplasma PneumoniaeGSB · Traditional | Institute Virion , Ltd. | 10/25/1984SE |
| K832132 | Sera-Tek Mycoplasma Antibody TestGSB · Traditional | Miles Laboratories, Inc. | 09/20/1983SE |
| K802934 | Mycoplasma Pneumoniae Antigen & ControlGSB · Traditional | Orion Diagnostica, Inc. | 12/31/1980SE |
More from Orion Diagnostica, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K913618 | Arbovirus Igm Ifa TestGQC · Traditional | 12/03/1992SE |
| K913617 | Arbovirus Igg Ifa TestGQC · Traditional | 12/03/1992SE |
| K922374 | Q Fever Igm Ifa TestGPJ · Traditional | 10/21/1992SE |
| K913906 | Q Fever Igg Ifa TestGPJ · Traditional | 10/21/1992SE |
| K900206 | Lyme Disease Igm ElisaLSR · Traditional | 06/28/1991SE |
| K896594 | Ebv Vca Antibody (Igm)LJN · Traditional | 01/16/1990SE |
| K884829 | Ebv Early Antigen (R+D)JRY · Traditional | 04/12/1989SE |
| K883767 | Lyme Disease Ifa (Igm)LSR · Traditional | 03/15/1989SE |
| K884591 | Ebv-Vca Antibody (Igg)GNP · Traditional | 01/24/1989SE |
| K883487 | Lyme Disease Ifa (Igg)LSR · Traditional | 12/13/1988SE |
Questions and answers
When was Mycoplasma Pneumoniae CF Antigen cleared by the FDA?
Mycoplasma Pneumoniae CF Antigen (K834338) received a 510(k) decision of Substantially Equivalent on February 27, 1984, 77 days after the submission was received.
What is the product code of K834338?
The FDA product code is GSB – Antigens, Cf, All, Mycoplasma Spp., a Class I (low risk) device regulated under 21 CFR 866.3375.