Assay Strips
FDA 510(k) K803244 · Corning Costar Corp.
510(k) numberK803244
Submission
- Device name
- Assay Strips
- Applicant
- Corning Costar Corp.
Mchenry, IL, US - Received
- December 23, 1980
- Decision date
- February 2, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JTC – Device, Microtiter Diluting/Dispensing
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2500
- Specialty
- Microbiology
Other 510(k)s with product code JTC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K924907 | Filtermate Universal HarvesterJTC · Traditional | Packard Instrument Co., Inc. | 12/01/1992SE |
| K901808 | Micromate 196 Model A961960JTC · Traditional | Packard Instrument Co., Inc. | 06/20/1990SE |
| K894645 | Immulon 1,2,3,AND 4 Dividastrips TMJTC · Traditional | Dynatech Laboratories, Inc. | 10/17/1989SE |
| K892369 | Multi-Probe Head PlusJTC · Traditional | Hamilton Co. | 06/02/1989SE |
| K891768 | Genetic Systems Microplate WasherJTC · Traditional | Genetic Systems Corp. | 05/01/1989SE |
| K891766 | Genetic Systems Microplate Strip WasherJTC · Traditional | Genetic Systems Corp. | 05/01/1989SE |
| K891765 | Genetic Systems Pipettor/DilutorJTC · Traditional | Genetic Systems Corp. | 05/01/1989SE |
| K884695 | Washer 500 Microelisa SystemJTC · Traditional | Organon Teknika Corp. | 12/13/1988SE |
| K884125 | Bio-Tek Automated Microplate Washer Model EL403JTC · Traditional | Bio-Tek Instruments, Inc. | 12/02/1988SE |
| K874598 | Dynatech MR 250 Manual Microelisa ReaderJTC · Traditional | Dynatech Laboratories, Inc. | 11/20/1987SE |
More from Dynatech Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K871559 | Cell LifterLIB · Traditional | 05/15/1987SE |
| K860703 | U - Star (Micro-Star)LHI · Traditional | 05/06/1986SE |
| K823137 | OctapettesJTC · Traditional | 12/03/1982SE |
| K823138 | Cell ScraperKJA · Traditional | 11/29/1982SE |
| K803243 | Serocluster Flexible Vinyl U & V Pl.JTC · Traditional | 01/28/1981SE |
| K803242 | Serocluster Eia PlatesJTC · Traditional | 01/28/1981SE |
| K800240 | Serocluster U and VJTC · Traditional | 02/13/1980SE |
Questions and answers
When was Assay Strips cleared by the FDA?
Assay Strips (K803244) received a 510(k) decision of Substantially Equivalent on February 2, 1981, 41 days after the submission was received.
What is the product code of K803244?
The FDA product code is JTC – Device, Microtiter Diluting/Dispensing, a Class I (low risk) device regulated under 21 CFR 866.2500.