510(k) K831959
- Device
- RADIAL IMMUNO-TEST FOR HUMAN FACTOR B
- Applicant
- KENT LABORATORIES, INC.
- 510(k) number
- K831959
- Product code
- JZH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-07-19
- Date received
- 1983-06-17
- Regulation
- 866.5320
- Classification name
- Factor B, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3014325803
- 2050010
- 2050012
- 1528450
- 3019906
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JZH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K964843 | IMMAGE IMMUNOCHEMISTRY SYSTEM PROPERDIN FACTOR B (PFB) REAGENT | Beckman Instruments, Inc. | 1997-03-06 |
| K882623 | PROPERDIN FACTOR B FOR TECHNICON DPA-1(TM) SYSTEM | Technicon Instruments Corp. | 1988-07-08 |
| K811740 | KALLESTAD'S ENDOPLATE FACTOR B TEST | Kallestad Laboratories, Inc. | 1981-07-16 |
| K781016 | C3PA (GBG) PROPERDIN FACTOR B | Icl Scientific | 1978-08-14 |
| K772084 | LAS-R HUMAN C3 PROACTIVATOR TEST | Hyland Therapeutic Div., Travenol Laboratories | 1978-01-24 |
Legacy Summary#
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FDA Review#
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