Anti-Human Serum
FDA 510(k) K791282 · Diagnostica, Inc.
510(k) numberK791282
Submission
- Device name
- Anti-Human Serum
- Applicant
- Diagnostica, Inc.
Mchenry, IL, US - Received
- July 10, 1979
- Decision date
- October 17, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DGQ – Whole Blood Plasma, Antigen, Antiserum, Control
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.5700
- Specialty
- Immunology
More from Diagnostica, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K002756 | Ease-A-CultKHE · Traditional | 02/23/2001SE |
| K823348 | H. Influenza B Antisera for CieGRP · Traditional | 12/28/1982SE |
| K812434 | Diagnostic Kits & Kit ComponentsLHT · Traditional | 09/23/1981SE |
| K800398 | Paracontrol Abnormal Immunoglobulin ContDEW · Traditional | 03/12/1980SE |
| K791284 | Anti-Human Kappa SerumDFH · Traditional | 11/27/1979SE |
| K791283 | Anti-Human Lambda SerumDEH · Traditional | 11/27/1979SE |
| K791281 | Anti-Human Igg SerumDEW · Traditional | 11/27/1979SE |
| K791285 | Anti-Human GlobulinsDEW · Traditional | 10/17/1979SE |
| K790672 | Aspergillus Fumigatus, Aspergillus FlavuJWT · Traditional | 05/31/1979SE |
| K790671 | Dermatophytin OJXB · Traditional | 05/31/1979SE |
Questions and answers
When was Anti-Human Serum cleared by the FDA?
Anti-Human Serum (K791282) received a 510(k) decision of Substantially Equivalent on October 17, 1979, 99 days after the submission was received.
What is the product code of K791282?
The FDA product code is DGQ – Whole Blood Plasma, Antigen, Antiserum, Control, a Class I (low risk) device regulated under 21 CFR 866.5700.