510(k) K852933
- Device
- MYCOPLASMA SPP SEROLOGICAL REAGENTS
- Applicant
- MICROBIX BIOSYSTEMS, INC.
- 510(k) number
- K852933
- Product code
- GSB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-08-01
- Date received
- 1985-07-09
- Regulation
- 866.3375
- Classification name
- Antigens, Cf, All, Mycoplasma Spp.
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- WILLIAM J GASTLE
- Address
- 341 Bering Ave. Toronto, Ontario M9a 4x3 Canada CA
FDA Registration Numbers#
- 3005360469
- 3031590640
- 3014150341
- 3024463179
- 3043196750
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GSB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K843664 | MYCOPLASMA PNEUMONIAE | Institute Virion , Ltd. | 1984-10-25 |
| K834338 | MYCOPLASMA PNEUMONIAE CF ANTIGEN | Hillcrest Biologicals | 1984-02-27 |
| K832132 | SERA-TEK MYCOPLASMA ANTIBODY TEST | Miles Laboratories, Inc. | 1983-09-20 |
| K802934 | MYCOPLASMA PNEUMONIAE ANTIGEN & CONTROL | Orion Diagnostica, Inc. | 1980-12-31 |
Legacy Summary#
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FDA Review#
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