Micromedic Reagent Dispenser
FDA 510(k) K803252 · Micromedic Systems
510(k) numberK803252
Submission
- Device name
- Micromedic Reagent Dispenser
- Applicant
- Micromedic Systems
Mchenry, IL, US - Received
- December 23, 1980
- Decision date
- January 12, 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 |
|---|---|---|
| K923643 | MedicoolILO · Traditional | 03/31/1993SE |
| K872309 | Micromedic Combostat Lh/Fsh KitCGJ · Traditional | 07/31/1987SE |
| K871505 | Autopak Neonatal TSH Monoclonal Irma KitJLW · Traditional | 05/26/1987SE |
| K871008 | Micromedic Neonatal T4 KitCDX · Traditional | 05/26/1987SE |
| K870904 | Micromedic Neonatal TSH Monoclonal Irma KitJLW · Traditional | 05/26/1987SE |
| K870245 | Autopak TSH Monoclonal Irma KitJLW · Traditional | 04/01/1987SE |
| K862206 | Taurus (TM) Automatic Liquid Scintillation CounterJJJ · Traditional | 08/04/1986SE |
| K860813 | Micromedic HTSH Monoclonal Irma KitJLW · Traditional | 07/14/1986SE |
| K861262 | MMS T3 UptakeKHQ · Traditional | 05/23/1986SE |
| K861320 | MMS T4 Ria KitCDX · Traditional | 04/24/1986SE |
Questions and answers
When was Micromedic Reagent Dispenser cleared by the FDA?
Micromedic Reagent Dispenser (K803252) received a 510(k) decision of Substantially Equivalent on January 12, 1981, 20 days after the submission was received.
What is the product code of K803252?
The FDA product code is JTC – Device, Microtiter Diluting/Dispensing, a Class I (low risk) device regulated under 21 CFR 866.2500.