Serum, ALPHA-1-GLYCOPROTEIN Anti-Human
FDA 510(k) K760143 · Oxford Laboratories, Inc.
510(k) numberK760143
Submission
- Device name
- Serum, ALPHA-1-GLYCOPROTEIN Anti-Human
- Applicant
- Oxford Laboratories, Inc.
Mchenry, IL, US - Received
- June 29, 1976
- Decision date
- July 20, 1976
- 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 |
|---|---|---|---|
| K823765 | Anti Sera to Human OroscomucoidDEX · Traditional | Kent Laboratories, Inc. | 12/30/1982SE |
| 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 |
More from Icl Scientific
| 510(k) | Device | Decision |
|---|---|---|
| K780912 | Adjustable DispensorJQW · Traditional | 06/28/1978SE |
| K760148 | Serum, B1A Globulin C3C Goat Anti-HumanCZW · Traditional | 07/20/1976SE |
| K760147 | Serum, Igm Anti-Human AcidDFT · Traditional | 07/20/1976SE |
| K760146 | Serum, Iga Goat Anti-Human AcidCZP · Traditional | 07/20/1976SE |
| K760144 | Serum, Haptoglobin Goat Anti-Human AcidDAD · Traditional | 07/20/1976SE |
| K760079 | Reagent, Thyroxine T4 (#210)CDX · Traditional | 07/20/1976SE |
| K760078 | Reagent, Ria Triiodothyronine T3 (#200)CDP · Traditional | 07/20/1976SE |
| K760145 | Serum, Igg Goat Anti-Human AcidDEW · Traditional | 07/19/1976SE |
Questions and answers
When was Serum, ALPHA-1-GLYCOPROTEIN Anti-Human cleared by the FDA?
Serum, ALPHA-1-GLYCOPROTEIN Anti-Human (K760143) received a 510(k) decision of Substantially Equivalent on July 20, 1976, 21 days after the submission was received.
What is the product code of K760143?
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.