Hla Control Sera
FDA 510(k) K791118 · Calbiochem-Behring Corp.
510(k) numberK791118
Submission
- Device name
- Hla Control Sera
- Applicant
- Calbiochem-Behring Corp.
Mchenry, IL, US - Received
- June 15, 1979
- Decision date
- August 3, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LGO – Test, Leukocyte Typing
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.7675
- Specialty
- Hematology
Other 510(k)s with product code LGO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K894947 | Platelia Toxo Igg KitLGO · Traditional | Kallestad Diag, A Div. of Erbamont, Inc. | 03/23/1990SE |
| K874544 | Snap(R) Campylobacter Culture Ident Diagnostic KitLGO · Traditional | Molecular Biosystems, Inc. | 08/12/1988SE |
| K761009 | Lymphocyte Typing, Positive ControlLGO · Traditional | Hyland Therapeutic Div., Travenol Laboratories | 04/06/1977SE |
| K761008 | Lymphocyte Typing, Negative ControlLGO · Traditional | Hyland Therapeutic Div., Travenol Laboratories | 04/06/1977SE |
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| K831811 | Revolution Radial Immunodiffusion PlateJZQ · Traditional | 07/28/1983SE |
| K831036 | Ena Test Kit SM & RNP Auto AntibodyLLL · Traditional | 04/27/1983SE |
| K830214 | Aft System IIIDHN · Traditional | 03/09/1983SE |
| K820812 | Creatine Kinase-Mb KitJHY · Traditional | 04/12/1982SE |
| K813493 | Enzygnost TM Rubella IgmLFX · Traditional | 03/04/1982SE |
| K820088 | Aft System Proficiency Testing ProgramDBL · Traditional | 01/26/1982SE |
| K812458 | PadacJTO · Traditional | 09/23/1981SE |
| K810718 | C-Peptice ReagentsJKD · Traditional | 03/31/1981SE |
| K810669 | Pantrak E.K.CIW · Traditional | 03/31/1981SE |
| K810404 | Rheumatoid Factors Reference SerumDHR · Traditional | 03/11/1981SE |
Questions and answers
When was Hla Control Sera cleared by the FDA?
Hla Control Sera (K791118) received a 510(k) decision of Substantially Equivalent on August 3, 1979, 49 days after the submission was received.
What is the product code of K791118?
The FDA product code is LGO – Test, Leukocyte Typing, a Class I (low risk) device regulated under 21 CFR 864.7675.