Immunoplate III Radio Immunodiffusion
FDA 510(k) K770548 · Hyland Therapeutic Div., Travenol Laboratories
510(k) numberK770548
Submission
- Device name
- Immunoplate III Radio Immunodiffusion
- Applicant
- Hyland Therapeutic Div., Travenol Laboratories
Mchenry, IL, US - Received
- March 21, 1977
- Decision date
- April 15, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JZQ – Plates And Equipment, Radial Immunodiffusion
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.4800
- Specialty
- Immunology
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|---|---|---|---|
| K881174 | Rid Plate ReaderJZQ · Traditional | The Binding Site, Ltd. | 06/08/1988SE |
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| K831811 | Revolution Radial Immunodiffusion PlateJZQ · Traditional | Calbiochem-Behring Corp. | 07/28/1983SE |
| K792699 | Ouchterlony Agar PlatesJZQ · Traditional | Meridian Diagnostics, Inc. | 01/24/1980SE |
| K790646 | Helena Quiplate SystemJZQ · Traditional | Helena Laboratories | 05/23/1979SE |
| K761311 | Accraassay Rid KitsJZQ · Traditional | Miles Laboratories, Inc. | 12/30/1976SE |
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| K791113 | Low Ionic Strength Solution (Liss)KSG · Traditional | 06/28/1979SE |
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Questions and answers
When was Immunoplate III Radio Immunodiffusion cleared by the FDA?
Immunoplate III Radio Immunodiffusion (K770548) received a 510(k) decision of Substantially Equivalent on April 15, 1977, 25 days after the submission was received.
What is the product code of K770548?
The FDA product code is JZQ – Plates And Equipment, Radial Immunodiffusion, a Class I (low risk) device regulated under 21 CFR 866.4800.