SYNELISA TG ANTIBODIES/TPO ANTIBODIES
FDA 510(k) clearance K933123 · decided 1993-08-23
Clearance details
- K-number
- K933123
- Device name
- SYNELISA TG ANTIBODIES/TPO ANTIBODIES
- Applicant
- Elias U.S.A., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-06-28
- Decision date
- 1993-08-23
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- JZS
- Device class
- 1
- Regulation number
- 866.4500
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Osceola, WI, 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 |
|---|---|---|
| IMMUNODIFFUSION BAND INTENSIFYING FLUID (K812194) | American Scientific Products | 1981-08-31 |
| IMMUNOELECTROPHORESIS PROFILE KIT (K770566) | Kallestad Laboratories, Inc. | 1977-04-27 |
| STAIN, R-250, COOMASSIE BRILLIANT BLUE (K770718) | Kallestad Laboratories, Inc. | 1977-04-26 |
| IMMUNOELECTROFILM KIH (K770719) | Kallestad Laboratories, Inc. | 1977-04-26 |
| ELECTRO IMMUNO ASSAY KIT (K770150) | Millipore Corp. | 1977-02-01 |
Recalls involving this device
No recalls on record reference this clearance.