Immulon 4 Flat Bottom Plates & Removawell Strips
FDA 510(k) K881675 · Dynatech Laboratories, Inc.
510(k) numberK881675
Submission
- Device name
- Immulon 4 Flat Bottom Plates & Removawell Strips
- Applicant
- Dynatech Laboratories, Inc.
Chantilly, VA, US - Received
- April 18, 1988
- Decision date
- April 21, 1988
- 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 |
| 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 |
| 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 |
More from Miles Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K962265 | MLX Microtiter Plate LuminometerJSE · Traditional | 07/25/1996SE |
| K934111 | MR7000 with Time Manager Software (TMS)JQP · Traditional | 11/02/1994SE |
| K943701 | MRX Microplate ReaderJJQ · Traditional | 10/20/1994SE |
| K923456 | Microlite Microtiter Plate Luminometer ML3000JJQ · Traditional | 10/13/1992SE |
| K915896 | Microlite Microtiter Plate Luminometer ML2250/MODIJJQ · Traditional | 05/04/1992SE |
| K920888 | Microlite Microtiter Plate Luminometer ML2200KHO · Traditional | 03/19/1992SE |
| K913590 | Microlite ML 1000 Microtiter Plate LuminometerJJQ · Traditional | 10/25/1991SE |
| K895313 | Microlite ML 1000 (Model 3) Microplate LuminometerJJQ · Traditional | 10/17/1989SE |
| K894645 | Immulon 1,2,3,AND 4 Dividastrips TMJTC · Traditional | 10/17/1989SE |
| K894687 | Dynatech MR 5000, Catalog #011-976-0600JJQ · Traditional | 08/31/1989SE |
Questions and answers
When was Immulon 4 Flat Bottom Plates & Removawell Strips cleared by the FDA?
Immulon 4 Flat Bottom Plates & Removawell Strips (K881675) received a 510(k) decision of Substantially Equivalent on April 21, 1988, 3 days after the submission was received.
What is the product code of K881675?
The FDA product code is JZQ – Plates And Equipment, Radial Immunodiffusion, a Class I (low risk) device regulated under 21 CFR 866.4800.