MYCOPLASMA SPP SEROLOGICAL REAGENTS
FDA 510(k) clearance K852933 · decided 1985-08-01
Clearance details
- K-number
- K852933
- Device name
- MYCOPLASMA SPP SEROLOGICAL REAGENTS
- Applicant
- Microbix Biosystems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-07-09
- Decision date
- 1985-08-01
- Days to decision
- 23 days
- Clearance type
- Traditional
- Product code
- GSB
- Device class
- 1
- Regulation number
- 866.3375
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Canada, CA
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Microbix Biosystems
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MYCOPLASMA PNEUMONIAE (K843664) | Institute Virion , Ltd. | 1984-10-25 |
| MYCOPLASMA PNEUMONIAE CF ANTIGEN (K834338) | Hillcrest Biologicals | 1984-02-27 |
| SERA-TEK MYCOPLASMA ANTIBODY TEST (K832132) | Miles Laboratories, Inc. | 1983-09-20 |
| MYCOPLASMA PNEUMONIAE ANTIGEN & CONTROL (K802934) | Orion Diagnostica, Inc. | 1980-12-31 |
Recalls involving this device
No recalls on record reference this clearance.