Immage Immunochemistry System Properdin Factor B (PFB) Reagent
FDA 510(k) K964843 · Beckman Instruments, Inc.
510(k) numberK964843
Submission
- Device name
- Immage Immunochemistry System Properdin Factor B (PFB) Reagent
- Applicant
- Beckman Instruments, Inc.
Brea, CA, US - Received
- December 3, 1996
- Decision date
- March 6, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JZH – Factor B, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5320
- Specialty
- Immunology
Other 510(k)s with product code JZH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K882623 | Properdin Factor B for Technicon DPA-1(TM) SystemJZH · Traditional | Technicon Instruments Corp. | 07/08/1988SE |
| K831959 | Radial Immuno-Test for Human Factor BJZH · Traditional | Kent Laboratories, Inc. | 07/19/1983SE |
| K811740 | Kallestad's Endoplate Factor B TestJZH · Traditional | Kallestad Laboratories, Inc. | 07/16/1981SE |
| K781016 | C3PA (GBG) Properdin Factor BJZH · Traditional | Icl Scientific | 08/14/1978SE |
| K772084 | Las-R Human C3 Proactivator TestJZH · Traditional | Hyland Therapeutic Div., Travenol Laboratories | 01/24/1978SE |
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Questions and answers
When was Immage Immunochemistry System Properdin Factor B (PFB) Reagent cleared by the FDA?
Immage Immunochemistry System Properdin Factor B (PFB) Reagent (K964843) received a 510(k) decision of Substantially Equivalent on March 6, 1997, 93 days after the submission was received.
What is the product code of K964843?
The FDA product code is JZH – Factor B, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5320.