Helena Quiplate System
FDA 510(k) K790646 · Helena Laboratories
510(k) numberK790646
Submission
- Device name
- Helena Quiplate System
- Applicant
- Helena Laboratories
Mchenry, IL, US - Received
- March 30, 1979
- Decision date
- May 23, 1979
- 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
Other 510(k)s with product code JZQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K881174 | Rid Plate ReaderJZQ · Traditional | The Binding Site, Ltd. | 06/08/1988SE |
| K881675 | Immulon 4 Flat Bottom Plates & Removawell StripsJZQ · Traditional | Dynatech Laboratories, Inc. | 04/21/1988SE |
| K831811 | Revolution Radial Immunodiffusion PlateJZQ · Traditional | Calbiochem-Behring Corp. | 07/28/1983SE |
| K792699 | Ouchterlony Agar PlatesJZQ · Traditional | Meridian Diagnostics, Inc. | 01/24/1980SE |
| K770548 | Immunoplate III Radio ImmunodiffusionJZQ · Traditional | Hyland Therapeutic Div., Travenol Laboratories | 04/15/1977SE |
| K761311 | Accraassay Rid KitsJZQ · Traditional | Miles Laboratories, Inc. | 12/30/1976SE |
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Questions and answers
When was Helena Quiplate System cleared by the FDA?
Helena Quiplate System (K790646) received a 510(k) decision of Substantially Equivalent on May 23, 1979, 54 days after the submission was received.
What is the product code of K790646?
The FDA product code is JZQ – Plates And Equipment, Radial Immunodiffusion, a Class I (low risk) device regulated under 21 CFR 866.4800.