IMMAGE IMMUNOCHEMISTRY SYSTEM PROPERDIN FACTOR B (PFB) REAGENT
FDA 510(k) clearance K964843 · decided 1997-03-06
Clearance details
- K-number
- K964843
- Device name
- IMMAGE IMMUNOCHEMISTRY SYSTEM PROPERDIN FACTOR B (PFB) REAGENT
- Applicant
- Beckman Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-12-03
- Decision date
- 1997-03-06
- Days to decision
- 93 days
- Clearance type
- Traditional
- Product code
- JZH
- Device class
- 2
- Regulation number
- 866.5320
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Brea, 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 |
|---|---|---|
| PROPERDIN FACTOR B FOR TECHNICON DPA-1(TM) SYSTEM (K882623) | Technicon Instruments Corp. | 1988-07-08 |
| RADIAL IMMUNO-TEST FOR HUMAN FACTOR B (K831959) | Kent Laboratories, Inc. | 1983-07-19 |
| KALLESTAD'S ENDOPLATE FACTOR B TEST (K811740) | Kallestad Laboratories, Inc. | 1981-07-16 |
| C3PA (GBG) PROPERDIN FACTOR B (K781016) | Icl Scientific | 1978-08-14 |
| LAS-R HUMAN C3 PROACTIVATOR TEST (K772084) | Hyland Therapeutic Div., Travenol Laboratories | 1978-01-24 |
Recalls involving this device
No recalls on record reference this clearance.