ASSAY REAGENTS, LSA 290
FDA 510(k) clearance K790588 · decided 1979-05-15
Clearance details
- K-number
- K790588
- Device name
- ASSAY REAGENTS, LSA 290
- Applicant
- Kallestad Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-03-27
- Decision date
- 1979-05-15
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- JEW
- Device class
- 1
- Regulation number
- 872.6650
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Mchenry, IL, 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 |
|---|---|---|
| RABINOWITZ GUM MASSAGER (K862635) | Arnell, Inc. | 1986-09-25 |
| CHEW-DENT (K843406) | Senair-Mot | 1984-12-11 |
Recalls involving this device
No recalls on record reference this clearance.