Polypet
FDA 510(k) K860617 · Instrumed, Inc.
510(k) numberK860617
Submission
- Device name
- Polypet
- Applicant
- Instrumed, Inc.
Union Bridge, MD, US - Received
- February 19, 1986
- Decision date
- March 3, 1986
- 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 |
|---|---|---|
| K952038 | Clean-CuffKCY · Traditional | 07/11/1995SE |
| K940615 | AccutestKCY · Traditional | 05/19/1995SE |
| K924273 | AccuflateKCY · Traditional | 01/12/1993SE |
| K924373 | Accuflate Accessorie Cart W/Iv Pole and ClampBZN · Traditional | 11/25/1992SE |
| K910512 | AccuflateKCY · Traditional | 02/19/1991SE |
| K890014 | Disposable Color-CuffsKCY · Traditional | 01/24/1989SE |
Questions and answers
When was Polypet cleared by the FDA?
Polypet (K860617) received a 510(k) decision of Substantially Equivalent on March 3, 1986, 12 days after the submission was received.
What is the product code of K860617?
The FDA product code is JTC – Device, Microtiter Diluting/Dispensing, a Class I (low risk) device regulated under 21 CFR 866.2500.