ALPHA-1-ACID Glycoprotein Serum, Anti-Hu
FDA 510(k) K781023 · Icl Scientific
510(k) numberK781023
Submission
- Device name
- ALPHA-1-ACID Glycoprotein Serum, Anti-Hu
- Applicant
- Icl Scientific
Mchenry, IL, US - Received
- June 19, 1978
- Decision date
- August 14, 1978
- 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 |
| K760143 | Serum, ALPHA-1-GLYCOPROTEIN Anti-HumanDEX · Traditional | Oxford Laboratories, Inc. | 07/20/1976SE |
More from Oxford Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K883942 | Hycor Sentry Drugs of Abuse Urine ControlJJY · Traditional | 11/10/1988SE |
| K843565 | Kova Trol I,Ii, III Human Urine-DriedJJW · Traditional | 10/05/1984SE |
| K833761 | Therapeutic Drug ControlDKB · Traditional | 01/13/1984SE |
| K832823 | Enzymune-Test TSHJLW · Traditional | 10/14/1983SE |
| K831383 | Event-Test SlideJHJ · Traditional | 06/22/1983SE |
| K823199 | Enzyme-Test DigoxinKXT · Traditional | 11/29/1982SE |
| K822777 | Therapeutic Drug ControlDIF · Traditional | 10/08/1982SE |
| K822346 | Histimune Enzyme-Ana TestLJM · Traditional | 10/08/1982SE |
| K822465 | Enzymune System IJJE · Traditional | 09/14/1982SE |
| K821374 | Enzymune-Test InsulinCFP · Traditional | 05/28/1982SE |
Questions and answers
When was ALPHA-1-ACID Glycoprotein Serum, Anti-Hu cleared by the FDA?
ALPHA-1-ACID Glycoprotein Serum, Anti-Hu (K781023) received a 510(k) decision of Substantially Equivalent on August 14, 1978, 56 days after the submission was received.
What is the product code of K781023?
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.