Antiserum to Human Prealbumin
FDA 510(k) K850686 · Kent Laboratories, Inc.
510(k) numberK850686
Submission
- Device name
- Antiserum to Human Prealbumin
- Applicant
- Kent Laboratories, Inc.
Redmond, WA, US - Received
- February 21, 1985
- Decision date
- November 1, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JZJ – Prealbumin, Antigen, Antiserum, Control
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.5060
- Specialty
- Immunology
Other 510(k)s with product code JZJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K000661 | Randox PrealbuminJZJ · Traditional | Randox Laboratories, Ltd. | 04/13/2000SE |
| K972638 | Tina-Quant PrealbuminJZJ · Traditional | Boehringer Mannheim Corp. | 01/09/1998SE |
| K951966 | Human Prealbumin Radial Immunodiffusion KitJZJ · Traditional | Kent Laboratories, Inc. | 06/01/1995SE |
| K913672 | Prealbumin Immunological NL Test KitJZJ · Traditional | The Binding Site, Ltd. | 12/20/1991SE |
| K884298 | Spq(Tm) Test System for MicroalbuminJZJ · Traditional | Atlantic Antibodies | 11/02/1988SE |
| K884297 | Spq(Tm) Test System for PrealbuminJZJ · Traditional | Atlantic Antibodies | 11/02/1988SE |
| K883002 | QM300 Prealbumin Antibody PackJZJ · Traditional | Kallestad Diag, A Div. of Erbamont, Inc. | 09/22/1988SE |
| K851912 | Laser Prealbumin TestJZJ · Traditional | Behring Diagnostics, Inc. | 06/21/1985SE |
| K821135 | Prealbumin Enzyme ImmunoassayJZJ · Traditional | Abbott Laboratories | 05/05/1983SE |
| K772329 | Las-R Human Prealbumin TestJZJ · Traditional | Hyland Therapeutic Div., Travenol Laboratories | 02/03/1978SE |
More from Hyland Therapeutic Div., Travenol Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K951966 | Human Prealbumin Radial Immunodiffusion KitJZJ · Traditional | 06/01/1995SE |
| K951968 | Human C1Q Radial Immunodiffusion KitDAK · Traditional | 05/30/1995SE |
| K951967 | Human C1 Inactivator or C-1 Esterase Inhibitor Radial Immunodiffusion KitDBA · Traditional | 05/30/1995SE |
| K950102 | Human C-5 Radial Immunodiffusion KitDAY · Traditional | 04/10/1995SE |
| K850683 | 72 Determ. Size Radial Immunodiffusion Test ALPHA2DEB · Traditional | 11/27/1985SE |
| K850682 | 72 Determ. Size Radial Immuno. Test Human CeruloplDDB · Traditional | 11/25/1985SE |
| K850691 | Antiserum to Human Apolipoprotein A-IMSJ · Traditional | 11/01/1985SE |
| K850690 | Antiserum to Human Apolipoprotein BMSJ · Traditional | 11/01/1985SE |
| K831961 | Immunodiffusion Test Human AntithrombinJBQ · Traditional | 08/11/1983SE |
| K831960 | Test for Human Alpha One Acid Glyco-LKL · Traditional | 07/19/1983SE |
Questions and answers
When was Antiserum to Human Prealbumin cleared by the FDA?
Antiserum to Human Prealbumin (K850686) received a 510(k) decision of Substantially Equivalent on November 1, 1985, 253 days after the submission was received.
What is the product code of K850686?
The FDA product code is JZJ – Prealbumin, Antigen, Antiserum, Control, a Class I (low risk) device regulated under 21 CFR 866.5060.