Capra (Caprac-R) Wipetest and Well Counter
FDA 510(k) K946387 · Capintec, Inc.
510(k) numberK946387
Submission
- Device name
- Capra (Caprac-R) Wipetest and Well Counter
- Applicant
- Capintec, Inc.
Pittsburgh, PA, US - Received
- November 25, 1994
- Decision date
- March 30, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| 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 |
| K872429 | Iso-Data 100 Series Gamma CounterJJJ · Traditional | Iso-Data, Inc. | 08/21/1987SE |
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Questions and answers
When was Capra (Caprac-R) Wipetest and Well Counter cleared by the FDA?
Capra (Caprac-R) Wipetest and Well Counter (K946387) received a 510(k) decision of Substantially Equivalent on March 30, 1995, 125 days after the submission was received.
What is the product code of K946387?
The FDA product code is JJJ – Counter (Beta, Gamma) For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2320.