Platelia Toxo Igg Kit
FDA 510(k) K894947 · Kallestad Diag, A Div. of Erbamont, Inc.
510(k) numberK894947
Submission
- Device name
- Platelia Toxo Igg Kit
- Applicant
- Kallestad Diag, A Div. of Erbamont, Inc.
Chaska, MN, US - Received
- August 3, 1989
- Decision date
- March 23, 1990
- 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 |
|---|---|---|---|
| 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 |
| 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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| K897072 | NDS Thyroxine Test Kit & NDS Thyroxine CalibratorKLI · Traditional | 03/29/1990SE |
| K894948 | Platelia Toxo Igm KitLGD · Traditional | 03/15/1990SE |
Questions and answers
When was Platelia Toxo Igg Kit cleared by the FDA?
Platelia Toxo Igg Kit (K894947) received a 510(k) decision of Substantially Equivalent on March 23, 1990, 232 days after the submission was received.
What is the product code of K894947?
The FDA product code is LGO – Test, Leukocyte Typing, a Class I (low risk) device regulated under 21 CFR 864.7675.