HUMAN C-5 RADIAL IMMUNODIFFUSION KIT
FDA 510(k) clearance K950102 · decided 1995-04-10
Clearance details
- K-number
- K950102
- Device name
- HUMAN C-5 RADIAL IMMUNODIFFUSION KIT
- Applicant
- Kent Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-01-11
- Decision date
- 1995-04-10
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- DAY
- Device class
- 2
- Regulation number
- 866.5240
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Redmond, WA, 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 |
|---|---|---|
| HUMAN C5 RID KITS (K942326) | Jay H. Geller | 1995-08-24 |
| RADIAL IMMUNODIFFUSION KIT-COMPLEMENT (K772075) | Gelman Instrument Co. | 1978-02-03 |
Recalls involving this device
No recalls on record reference this clearance.