Taurus (TM) Automatic Liquid Scintillation Counter
FDA 510(k) K862206 · Micromedic Systems
510(k) numberK862206
Submission
- Device name
- Taurus (TM) Automatic Liquid Scintillation Counter
- Applicant
- Micromedic Systems
Horsham, PA, US - Received
- June 10, 1986
- Decision date
- August 4, 1986
- 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 |
|---|---|---|
| K923643 | MedicoolILO · Traditional | 03/31/1993SE |
| K872309 | Micromedic Combostat Lh/Fsh KitCGJ · Traditional | 07/31/1987SE |
| K871505 | Autopak Neonatal TSH Monoclonal Irma KitJLW · Traditional | 05/26/1987SE |
| K871008 | Micromedic Neonatal T4 KitCDX · Traditional | 05/26/1987SE |
| K870904 | Micromedic Neonatal TSH Monoclonal Irma KitJLW · Traditional | 05/26/1987SE |
| K870245 | Autopak TSH Monoclonal Irma KitJLW · Traditional | 04/01/1987SE |
| K860813 | Micromedic HTSH Monoclonal Irma KitJLW · Traditional | 07/14/1986SE |
| K861262 | MMS T3 UptakeKHQ · Traditional | 05/23/1986SE |
| K861320 | MMS T4 Ria KitCDX · Traditional | 04/24/1986SE |
| K853127 | Micromedic Combostat B B12/FOLATE(BOIL)CDD · Traditional | 09/16/1985SE |
Questions and answers
When was Taurus (TM) Automatic Liquid Scintillation Counter cleared by the FDA?
Taurus (TM) Automatic Liquid Scintillation Counter (K862206) received a 510(k) decision of Substantially Equivalent on August 4, 1986, 55 days after the submission was received.
What is the product code of K862206?
The FDA product code is JJJ – Counter (Beta, Gamma) For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2320.