Human Alpha, Acid Glycoprotein
FDA 510(k) K791341 · Beckman Instruments, Inc.
510(k) numberK791341
Submission
- Device name
- Human Alpha, Acid Glycoprotein
- Applicant
- Beckman Instruments, Inc.
Mchenry, IL, US - Received
- July 16, 1979
- Decision date
- August 16, 1979
- 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 |
| 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 |
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Questions and answers
When was Human Alpha, Acid Glycoprotein cleared by the FDA?
Human Alpha, Acid Glycoprotein (K791341) received a 510(k) decision of Substantially Equivalent on August 16, 1979, 31 days after the submission was received.
What is the product code of K791341?
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.