SERA-TEK MYCOPLASMA ANTIBODY TEST
FDA 510(k) clearance K832132 · decided 1983-09-20
Clearance details
- K-number
- K832132
- Device name
- SERA-TEK MYCOPLASMA ANTIBODY TEST
- Applicant
- Miles Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-07-01
- Decision date
- 1983-09-20
- Days to decision
- 81 days
- Clearance type
- Traditional
- Product code
- GSB
- Device class
- 1
- Regulation number
- 866.3375
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MYCOPLASMA SPP SEROLOGICAL REAGENTS (K852933) | Microbix Biosystems, Inc. | 1985-08-01 |
| MYCOPLASMA PNEUMONIAE (K843664) | Institute Virion , Ltd. | 1984-10-25 |
| MYCOPLASMA PNEUMONIAE CF ANTIGEN (K834338) | Hillcrest Biologicals | 1984-02-27 |
| MYCOPLASMA PNEUMONIAE ANTIGEN & CONTROL (K802934) | Orion Diagnostica, Inc. | 1980-12-31 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| BIOSTATOR GLUCOSE CONTROLLER (P800032/S001) | Miles Laboratories, Inc. | 1983-06-02 |
| BIOSTATOR GLUCOSE CONTROLLER (P800032) | Miles Laboratories, Inc. | 1981-05-28 |