TFR
FDA 510(k) clearance K981208 · decided 1998-10-21
Clearance details
- K-number
- K981208
- Device name
- TFR
- Applicant
- Ramco Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-04-02
- Decision date
- 1998-10-21
- Days to decision
- 202 days
- Clearance type
- Traditional
- Product code
- JNM
- Device class
- 2
- Regulation number
- 866.5880
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Houston, TX, 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 |
|---|---|---|
| NICHOLS ADVANTAGE CHEMILUMINESCENCE SOLUBLE TRANSFERRIN RECEPTOR IMMUNOASSAY, MODEL 62-7028 (K992188) | Nichols Institute Diagnostics | 1999-12-06 |
| QUANTIKINE IVD STFR ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) (K970718) | R&D Systems, Inc. | 1997-05-27 |
Recalls involving this device
No recalls on record reference this clearance.