HELENA QUIPLATE SYSTEM
FDA 510(k) clearance K790646 · decided 1979-05-23
Clearance details
- K-number
- K790646
- Device name
- HELENA QUIPLATE SYSTEM
- Applicant
- Helena Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1979-03-30
- Decision date
- 1979-05-23
- Days to decision
- 54 days
- Clearance type
- Traditional
- Product code
- JZQ
- Device class
- 1
- Regulation number
- 866.4800
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| RID PLATE READER (K881174) | The Binding Site, Ltd. | 1988-06-08 |
| IMMULON 4 FLAT BOTTOM PLATES & REMOVAWELL STRIPS (K881675) | Dynatech Laboratories, Inc. | 1988-04-21 |
| REVOLUTION RADIAL IMMUNODIFFUSION PLATE (K831811) | Calbiochem-Behring Corp. | 1983-07-28 |
| OUCHTERLONY AGAR PLATES (K792699) | Meridian Diagnostics, Inc. | 1980-01-24 |
| IMMUNOPLATE III RADIO IMMUNODIFFUSION (K770548) | Hyland Therapeutic Div., Travenol Laboratories | 1977-04-15 |
| ACCRAASSAY RID KITS (K761311) | Miles Laboratories, Inc. | 1976-12-30 |
Recalls involving this device
No recalls on record reference this clearance.