Spor-O-Therm
FDA 510(k) K801462 · Mdt Corp., Inc.
510(k) numberK801462
Submission
- Device name
- Spor-O-Therm
- Applicant
- Mdt Corp., Inc.
Mchenry, IL, US - Received
- June 24, 1980
- Decision date
- July 28, 1980
- 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 |
| K853379 | Plate IncubatorJTQ · Traditional | Scientific Sales Intl., Inc. | 09/03/1985SE |
| 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 |
| K792060 | Temptronic 100 Water BathJTQ · Traditional | Sybron Corp. | 12/04/1979SE |
More from Sybron Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K960777 | MDT Unispore and Spor-Test BiologicalindicatorFRC · Traditional | 05/23/1996SE |
| K942485 | MDT Urology TableMMZ · Traditional | 08/26/1994SE |
| K942486 | Image Full Power Examination/Minor Surgery TableFQO · Traditional | 08/10/1994SE |
| K924380 | Mdt/Harvey Model 7000 & 8000 ChemiclaveMLR · Traditional | 02/16/1994SE |
| K926081 | Dental LightEAZ · Traditional | 01/26/1994SE |
| K924955 | Mdt/Harvey MC-8 and MC-10FLE · Traditional | 10/15/1993SE |
| K932094 | Bovie Ultrasonic Surgical AspiratorLFL · Traditional | 07/21/1993SE |
| K931169 | MDT Dental ChairKLC · Traditional | 05/20/1993SE |
| K920930 | Mdt/Castle 10/90 Dual Load StationFLF · Traditional | 03/31/1993SE |
| K922212 | MDT Castle Biosign Test PackFRC · Traditional | 08/10/1992SE |
Questions and answers
When was Spor-O-Therm cleared by the FDA?
Spor-O-Therm (K801462) received a 510(k) decision of Substantially Equivalent on July 28, 1980, 34 days after the submission was received.
What is the product code of K801462?
The FDA product code is JTQ – Bath, Incubators/Water, All, a Class I (low risk) device regulated under 21 CFR 866.2540.