Immu-Count 404
FDA 510(k) K822293 · Kemble Instruments, Inc.
510(k) numberK822293
Submission
- Device name
- Immu-Count 404
- Applicant
- Kemble Instruments, Inc.
Mchenry, IL, US - Received
- August 2, 1982
- Decision date
- August 24, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJJ – Counter (Beta, Gamma) For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2320
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JJJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K962762 | Sequential Sample Multi-Photon DetectorJJJ · Traditional | Biotraces, Inc. | 08/16/1996SE |
| K946387 | Capra (Caprac-R) Wipetest and Well CounterJJJ · Traditional | Capintec, Inc. | 03/30/1995SE |
| K920559 | Abbott Vertex AnalyzerJJJ · Traditional | Abbott Laboratories | 03/19/1992SE |
| K900087 | Genesys 6000 Gamma CounterJJJ · Traditional | Laboratory Technologies, Inc. | 07/19/1990SE |
| K896202 | MATRIX(TM)-96JJJ · Traditional | Canberra Industries, Inc. | 01/02/1990SE |
| K894902 | SourcererJJJ · Traditional | Oakfield Instruments, Ltd. | 10/17/1989SE |
| K884091 | SourcererJJJ · Traditional | John Caunt Scientific , Ltd. | 02/02/1989SE |
| K884269 | Sample Identification Station Model 38010JJJ · Traditional | Icn Micromedic Systems | 01/09/1989SE |
| K874094 | 1205 Betaplate Liquid Scintillation CounterJJJ · Traditional | Lkb Instruments, Inc. | 11/04/1987SE |
| K872430 | Iso-Data 500 Series Gamma CounterJJJ · Traditional | Iso-Data, Inc. | 08/21/1987SE |
More from Iso-Data, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K842894 | Kemble 405JQW · Traditional | 08/27/1984SE |
| K832760 | Ria SoftwareJQP · Traditional | 10/14/1983SE |
| K832734 | Kemtek 400 Ria Gamma CounterJJJ · Traditional | 10/14/1983SE |
| K832736 | Kemtek 104 Ria Gamma CounterJJJ · Traditional | 09/29/1983SE |
| K832735 | Kemtek 103 Ria Gamma CounterJJJ · Traditional | 09/29/1983SE |
| K830751 | Kemtek 102JJJ · Traditional | 04/06/1983SE |
| K827748 | Thyro-Count Thyroid Uptake System 90IZD Probe · Traditional | 08/16/1982SE |
| K820137 | Immu-CountJJJ · Traditional | 02/05/1982SE |
Questions and answers
When was Immu-Count 404 cleared by the FDA?
Immu-Count 404 (K822293) received a 510(k) decision of Substantially Equivalent on August 24, 1982, 22 days after the submission was received.
What is the product code of K822293?
The FDA product code is JJJ – Counter (Beta, Gamma) For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2320.