JTQ · Bath, Incubators/Water, All
Microbiology · 21 CFR 866.2540 · Class 1
Overview
| Product Code | JTQ |
|---|---|
| Device Name | Bath, Incubators/Water, All |
| Regulation | 21 CFR 866.2540 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
| GMP Exempt | Yes |
Identification
A microbiological incubator is a device with various chambers or water-filled compartments in which controlled environmental conditions, particularly temperature, are maintained. It is intended for medical purposes to cultivate microorganisms and aid in the diagnosis of disease.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9. The device is also exempt from the good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (12 of 12)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K875275 | WINTHROP PHARMACEUTICALS CONTRAST MEDIA WARMER | Sterling Drug, Inc. | Jan 27, 1988 | SESE |
| K853379 | PLATE INCUBATOR | Scientific Sales Intl., Inc. | Sep 3, 1985 | SESE |
| K831592 | ANHYDRIC INCUBATORS, CULTURE INCUBATOR | Boekel Industries, Inc. | Jun 16, 1983 | SESE |
| K830322 | C.A.T. REAGENT KIT | Remel Co. | Mar 28, 1983 | SESE |
| K830405 | LBI-100 37DEGREES INCUBATOR | Bionetic Laboratory Products | Mar 10, 1983 | SESE |
| K830227 | AUTOMATED ELISA READER LBI 300 | Bionetic Laboratory Products | Mar 10, 1983 | SESE |
| K822564 | WATER BATH | Boekel Industries, Inc. | Sep 14, 1982 | SESE |
| K812826 | FORMA CH/P GAS PROCESSOR | Forma Scientific, Inc. | Oct 23, 1981 | SESE |
| K812340 | TITERTEK MICROPLATE INCUBATOR | Flow Laboratories, Inc. | Sep 23, 1981 | SESE |
| K801462 | SPOR-O-THERM | Mdt Corp., Inc. | Jul 28, 1980 | SESE |
| K792060 | TEMPTRONIC 100 WATER BATH | Sybron Corp. | Dec 4, 1979 | SESE |
| K760928 | BLOOD BANK DRI-BATH | Thermolyne Corp. | Jan 10, 1977 | SESE |
Top Applicants
- Bionetic Laboratory Products — 2 clearances
- Boekel Industries, Inc. — 2 clearances
- Flow Laboratories, Inc. — 1 clearance
- Forma Scientific, Inc. — 1 clearance
- Mdt Corp., Inc. — 1 clearance
