Lymphocyte Typing, Positive Control
FDA 510(k) K761009 · Hyland Therapeutic Div., Travenol Laboratories
510(k) numberK761009
Submission
- Device name
- Lymphocyte Typing, Positive Control
- Applicant
- Hyland Therapeutic Div., Travenol Laboratories
Mchenry, IL, US - Received
- November 2, 1976
- Decision date
- April 6, 1977
- 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 |
| K791118 | Hla Control SeraLGO · Traditional | Calbiochem-Behring Corp. | 08/03/1979SE |
| K761008 | Lymphocyte Typing, Negative ControlLGO · Traditional | Hyland Therapeutic Div., Travenol Laboratories | 04/06/1977SE |
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| K812220 | Nephelometric Solid Turbidity StandardJIW · Traditional | 08/18/1981SE |
| K810078 | Q-Pak Therapeutic Drug Monit. Control SDIF · Traditional | 02/02/1981SE |
| K810077 | Omega Therapeutic Drug Monit. Control S.DIF · Traditional | 01/28/1981SE |
| K802610 | Alert A,Hdl-Apoliporotein a, Test KitDER · Traditional | 01/05/1981SE |
| K791113 | Low Ionic Strength Solution (Liss)KSG · Traditional | 06/28/1979SE |
| K790249 | Test CellsKSF · Traditional | 05/16/1979SE |
| K781225 | Globulin Test, Human Thyroxine BindingCEE · Traditional | 08/31/1978SE |
| K780962 | Automated EnzymeKSK · Traditional | 07/27/1978SE |
Questions and answers
When was Lymphocyte Typing, Positive Control cleared by the FDA?
Lymphocyte Typing, Positive Control (K761009) received a 510(k) decision of Substantially Equivalent on April 6, 1977, 155 days after the submission was received.
What is the product code of K761009?
The FDA product code is LGO – Test, Leukocyte Typing, a Class I (low risk) device regulated under 21 CFR 864.7675.