Anti Sera to Human Oroscomucoid
FDA 510(k) K823765 · Kent Laboratories, Inc.
510(k) numberK823765
Submission
- Device name
- Anti Sera to Human Oroscomucoid
- Applicant
- Kent Laboratories, Inc.
Walker, MI, US - Received
- December 14, 1982
- Decision date
- December 30, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DEX – Alpha-1-B-Glycoprotein, Antigen, Antiserum, Control
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.5420
- Specialty
- Immunology
Other 510(k)s with product code DEX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K801909 | Lsa 290 Assay Reagents/NephelometricDEX · Traditional | J.T. Baker Chemical Co. | 09/26/1980SE |
| K791341 | Human Alpha, Acid GlycoproteinDEX · Traditional | Beckman Instruments, Inc. | 08/16/1979SE |
| K781023 | ALPHA-1-ACID Glycoprotein Serum, Anti-HuDEX · Traditional | Icl Scientific | 08/14/1978SE |
| K760143 | Serum, ALPHA-1-GLYCOPROTEIN Anti-HumanDEX · Traditional | Oxford Laboratories, Inc. | 07/20/1976SE |
More from Oxford Laboratories, Inc.
| 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 |
| K850686 | Antiserum to Human PrealbuminJZJ · Traditional | 11/01/1985SE |
| K831961 | Immunodiffusion Test Human AntithrombinJBQ · Traditional | 08/11/1983SE |
Questions and answers
When was Anti Sera to Human Oroscomucoid cleared by the FDA?
Anti Sera to Human Oroscomucoid (K823765) received a 510(k) decision of Substantially Equivalent on December 30, 1982, 16 days after the submission was received.
What is the product code of K823765?
The FDA product code is DEX – Alpha-1-B-Glycoprotein, Antigen, Antiserum, Control, a Class I (low risk) device regulated under 21 CFR 866.5420.