Api Uniscept Plus 140 Inoculator
FDA 510(k) K831462 · Analytical Products, Inc.
510(k) numberK831462
Submission
- Device name
- Api Uniscept Plus 140 Inoculator
- Applicant
- Analytical Products, Inc.
Walker, MI, US - Received
- May 6, 1983
- Decision date
- August 12, 1983
- 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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| K894645 | Immulon 1,2,3,AND 4 Dividastrips TMJTC · Traditional | Dynatech Laboratories, Inc. | 10/17/1989SE |
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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 |
| K874598 | Dynatech MR 250 Manual Microelisa ReaderJTC · Traditional | Dynatech Laboratories, Inc. | 11/20/1987SE |
More from Dynatech Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K924814 | Api 20E/UNISCEPT 20EJSS · Traditional | 03/11/1993SE |
| K923684 | Api Uniscept Mic/Type 2 and 3 and Micro MicJWY · Traditional | 12/03/1992SE |
| K922926 | Api Uniscept Kb/Type 2 and 3JWY · Traditional | 10/13/1992SE |
| K901559 | Modification to Api Uniscept 20GPLQL · Traditional | 09/10/1990SE |
| K901390 | Dmac Indole ReagentJTO · Traditional | 04/16/1990SE |
| K895796 | Api Uniscept KBJWY · Traditional | 11/13/1989SE |
| K884510 | Modification Micro-MicJWY · Traditional | 11/22/1988SE |
| K884509 | Modification Mic/Api Uniscept(R)JWY · Traditional | 11/22/1988SE |
| K880598 | Modifications to Api Uniscept (R) KBJWY · Traditional | 03/23/1988SE |
| K874466 | Api Uniscept(R) Micro-Mic(R) System/Uniscept MicJWY · Traditional | 12/09/1987SE |
Questions and answers
When was Api Uniscept Plus 140 Inoculator cleared by the FDA?
Api Uniscept Plus 140 Inoculator (K831462) received a 510(k) decision of Substantially Equivalent on August 12, 1983, 98 days after the submission was received.
What is the product code of K831462?
The FDA product code is JTC – Device, Microtiter Diluting/Dispensing, a Class I (low risk) device regulated under 21 CFR 866.2500.