HUMAN C5 RID KITS
FDA 510(k) clearance K942326 · decided 1995-08-24
Clearance details
- K-number
- K942326
- Device name
- HUMAN C5 RID KITS
- Applicant
- Jay H. Geller
- Decision
- Substantially Equivalent
- Date received
- 1994-05-13
- Decision date
- 1995-08-24
- Days to decision
- 468 days
- Clearance type
- Traditional
- Product code
- DAY
- Device class
- 2
- Regulation number
- 866.5240
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Santa Monica, 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 |
|---|---|---|
| HUMAN C-5 RADIAL IMMUNODIFFUSION KIT (K950102) | Kent Laboratories, Inc. | 1995-04-10 |
| RADIAL IMMUNODIFFUSION KIT-COMPLEMENT (K772075) | Gelman Instrument Co. | 1978-02-03 |
Recalls involving this device
No recalls on record reference this clearance.