Bath, Incubators/Water, All
Bath, Incubators/Water, All is a laboratory instrument category encompassing water baths and incubators used to maintain specimens, culture media, or reagents at controlled temperatures required for microbiological and biochemical analyses. It is classified as FDA Class 1, the lowest risk category, subject to general controls only. The product code is JTQ, regulated under 21 CFR 866.2540, and falls within the Microbiology medical specialty. This device is exempt from Good Manufacturing Practice (GMP) regulations.
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Basic Information
- Product Code
- JTQ
- Device Class
- FDA class 1
- Regulation Number
- 866.2540
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 12 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K875275 | WINTHROP PHARMACEUTICALS CONTRAST MEDIA WARMER | Jan 27, 1988 | Substantially Equivalent | Sterling Drug, Inc. |
| K853379 | PLATE INCUBATOR | Sep 03, 1985 | Substantially Equivalent | Scientific Sales Intl., Inc. |
| K831592 | ANHYDRIC INCUBATORS, CULTURE INCUBATOR | Jun 16, 1983 | Substantially Equivalent | Boekel Industries, Inc. |
| K830322 | C.A.T. REAGENT KIT | Mar 28, 1983 | Substantially Equivalent | Remel Co. |
| K830405 | LBI-100 37DEGREES INCUBATOR | Mar 10, 1983 | Substantially Equivalent | Bionetic Laboratory Products |
| K830227 | AUTOMATED ELISA READER LBI 300 | Mar 10, 1983 | Substantially Equivalent | Bionetic Laboratory Products |
| K822564 | WATER BATH | Sep 14, 1982 | Substantially Equivalent | Boekel Industries, Inc. |
| K812826 | FORMA CH/P GAS PROCESSOR | Oct 23, 1981 | Substantially Equivalent | Forma Scientific, Inc. |
| K812340 | TITERTEK MICROPLATE INCUBATOR | Sep 23, 1981 | Substantially Equivalent | Flow Laboratories, Inc. |
| K801462 | SPOR-O-THERM | Jul 28, 1980 | Substantially Equivalent | Mdt Corp., Inc. |
| K792060 | TEMPTRONIC 100 WATER BATH | Dec 04, 1979 | Substantially Equivalent | Sybron Corp. |
| K760928 | BLOOD BANK DRI-BATH | Jan 10, 1977 | Substantially Equivalent | Thermolyne Corp. |
FEI Numbers
This FDA classification entry is associated with 54 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 54 registration numbers. Click on an entry to view related FDA registrations.