LIGHT DIAGNOSTICS RABIES DFA REAGENT
FDA 510(k) clearance K972975 · decided 1998-12-22
Clearance details
- K-number
- K972975
- Device name
- LIGHT DIAGNOSTICS RABIES DFA REAGENT
- Applicant
- Light Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 1997-08-11
- Decision date
- 1998-12-22
- Days to decision
- 498 days
- Clearance type
- Traditional
- Product code
- GOI
- Device class
- 2
- Regulation number
- 866.3460
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Temecula, CA, 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 |
|---|---|---|
| FITC ANTI-RABIES MONOCLONAL GLOBULIN (K820499) | Centocor, Inc. | 1982-04-16 |
Recalls involving this device
No recalls on record reference this clearance.