Plate Incubator
FDA 510(k) K853379 · Scientific Sales Intl., Inc.
510(k) numberK853379
Submission
- Device name
- Plate Incubator
- Applicant
- Scientific Sales Intl., Inc.
Kalamazoo, MI, US - Received
- August 12, 1985
- Decision date
- September 3, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JTQ – Bath, Incubators/Water, All
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2540
- Specialty
- Microbiology
Other 510(k)s with product code JTQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K875275 | Winthrop Pharmaceuticals Contrast Media WarmerJTQ · Traditional | Sterling Drug, Inc. | 01/27/1988SE |
| K831592 | Anhydric Incubators, Culture IncubatorJTQ · Traditional | Boekel Industries, Inc. | 06/16/1983SE |
| K830322 | C.A.T. Reagent KitJTQ · Traditional | Remel Co. | 03/28/1983SE |
| K830405 | LBI-100 37DEGREES IncubatorJTQ · Traditional | Bionetic Laboratory Products | 03/10/1983SE |
| K830227 | Automated Elisa Reader Lbi 300JTQ · Traditional | Bionetic Laboratory Products | 03/10/1983SE |
| K822564 | Water BathJTQ · Traditional | Boekel Industries, Inc. | 09/14/1982SE |
| K812826 | Forma Ch/P Gas ProcessorJTQ · Traditional | Forma Scientific, Inc. | 10/23/1981SE |
| K812340 | Titertek Microplate IncubatorJTQ · Traditional | Flow Laboratories, Inc. | 09/23/1981SE |
| K801462 | Spor-O-ThermJTQ · Traditional | Mdt Corp., Inc. | 07/28/1980SE |
| K792060 | Temptronic 100 Water BathJTQ · Traditional | Sybron Corp. | 12/04/1979SE |
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|---|---|---|
| K953677 | Lighted Flexguide (Modification)BSR · Traditional | 08/25/1995SE |
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| K860996 | Sanassay Ic TestDAK · Traditional | 03/30/1987SE |
| K862087 | Santest 1APLKL · Traditional | 12/03/1986SE |
| K861336 | Iap Plate TestLKL · Traditional | 04/25/1986SE |
| K853285 | Mywasher 5LIB · Traditional | 10/04/1985SE |
| K853284 | Myreader 7JJQ · Traditional | 10/04/1985SE |
| K853380 | SPR 2 AutodiluterJTC · Traditional | 09/12/1985SE |
| K833022 | Air Uterine Displacer-Aud 120CCX · Traditional | 10/14/1983SE |
| K802416 | Salem/Resce Intubation GuideBSR · Traditional | 10/23/1980SE |
Questions and answers
When was Plate Incubator cleared by the FDA?
Plate Incubator (K853379) received a 510(k) decision of Substantially Equivalent on September 3, 1985, 22 days after the submission was received.
What is the product code of K853379?
The FDA product code is JTQ – Bath, Incubators/Water, All, a Class I (low risk) device regulated under 21 CFR 866.2540.