Code-A-Well 350 Microtitration Strips
FDA 510(k) K842848 · Plastic Injectors, Inc.
510(k) numberK842848
Submission
- Device name
- Code-A-Well 350 Microtitration Strips
- Applicant
- Plastic Injectors, Inc.
Mchenry, IL, US - Received
- July 20, 1984
- Decision date
- September 7, 1984
- 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 |
|---|---|---|
| K884781 | Opti-PointHET · Traditional | 01/12/1989SE |
| K863423 | Code-A-Well Series 1-1000 and Series 1-1100JTC · Traditional | 09/16/1986SE |
| K863374 | Code-A-Well Series 1-600, 1-625JTC · Traditional | 09/11/1986SE |
| K844058 | Code-A-Wall Series 1-250 Inoculum Tray · Traditional | 11/13/1984SE |
| K841632 | Code-A-Well Series 200 PlateLIB · Traditional | 05/25/1984SE |
| K841937 | Code-A-Well Series 300 PlateLIB · Traditional | 05/22/1984SE |
| K841390 | Code-A-WellLIB · Traditional | 05/02/1984SE |
Questions and answers
When was Code-A-Well 350 Microtitration Strips cleared by the FDA?
Code-A-Well 350 Microtitration Strips (K842848) received a 510(k) decision of Substantially Equivalent on September 7, 1984, 49 days after the submission was received.
What is the product code of K842848?
The FDA product code is JTC – Device, Microtiter Diluting/Dispensing, a Class I (low risk) device regulated under 21 CFR 866.2500.