Cap-Ria 16
FDA 510(k) K823240 · Capintec, Inc.
510(k) numberK823240
Submission
- Device name
- Cap-Ria 16
- Applicant
- Capintec, Inc.
Mchenry, IL, US - Received
- November 1, 1982
- Decision date
- December 3, 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 |
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| K101452 | Capintec CRC 55T Series Dose Calibrators, Models CRC 55TR, CRC 55TPET and CRC 55TWKPT · Special | 08/09/2010SE |
| K071396 | CRC 25 Series (CRC 25R, CRC 25PET, CRC 25W) Dose CalibratorsKPT · Special | 06/28/2007SE |
| K052595 | CRC 15ULTRAJAQ · Traditional | 11/08/2005SE |
| K030175 | 2 BasicIYE · Traditional | 04/17/2003SE |
| K020150 | CRC-15BTKPT · Traditional | 08/02/2002SE |
| K982448 | CardiolightDSH · Traditional | 06/11/1999SE |
| K980402 | Capintec Model 292 ElectrometerIYE · Traditional | 04/24/1998SE |
Questions and answers
When was Cap-Ria 16 cleared by the FDA?
Cap-Ria 16 (K823240) received a 510(k) decision of Substantially Equivalent on December 3, 1982, 32 days after the submission was received.
What is the product code of K823240?
The FDA product code is JJJ – Counter (Beta, Gamma) For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2320.