SPR 2 Autodiluter
FDA 510(k) K853380 · Scientific Sales Intl., Inc.
510(k) numberK853380
Submission
- Device name
- SPR 2 Autodiluter
- Applicant
- Scientific Sales Intl., Inc.
Kalamazoo, MI, US - Received
- August 12, 1985
- Decision date
- September 12, 1985
- 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
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| 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 |
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| K853285 | Mywasher 5LIB · Traditional | 10/04/1985SE |
| K853284 | Myreader 7JJQ · Traditional | 10/04/1985SE |
| K853379 | Plate IncubatorJTQ · Traditional | 09/03/1985SE |
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Questions and answers
When was SPR 2 Autodiluter cleared by the FDA?
SPR 2 Autodiluter (K853380) received a 510(k) decision of Substantially Equivalent on September 12, 1985, 31 days after the submission was received.
What is the product code of K853380?
The FDA product code is JTC – Device, Microtiter Diluting/Dispensing, a Class I (low risk) device regulated under 21 CFR 866.2500.