WATER BATH
FDA 510(k) clearance K822564 · decided 1982-09-14
Clearance details
- K-number
- K822564
- Device name
- WATER BATH
- Applicant
- Boekel Industries, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-08-24
- Decision date
- 1982-09-14
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- JTQ
- Device class
- 1
- Regulation number
- 866.2540
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| WINTHROP PHARMACEUTICALS CONTRAST MEDIA WARMER (K875275) | Sterling Drug, Inc. | 1988-01-27 |
| PLATE INCUBATOR (K853379) | Scientific Sales Intl., Inc. | 1985-09-03 |
| ANHYDRIC INCUBATORS, CULTURE INCUBATOR (K831592) | Boekel Industries, Inc. | 1983-06-16 |
| C.A.T. REAGENT KIT (K830322) | Remel Co. | 1983-03-28 |
| AUTOMATED ELISA READER LBI 300 (K830227) | Bionetic Laboratory Products | 1983-03-10 |
| LBI-100 37DEGREES INCUBATOR (K830405) | Bionetic Laboratory Products | 1983-03-10 |
| FORMA CH/P GAS PROCESSOR (K812826) | Forma Scientific, Inc. | 1981-10-23 |
| TITERTEK MICROPLATE INCUBATOR (K812340) | Flow Laboratories, Inc. | 1981-09-23 |
| SPOR-O-THERM (K801462) | Mdt Corp., Inc. | 1980-07-28 |
| TEMPTRONIC 100 WATER BATH (K792060) | Sybron Corp. | 1979-12-04 |
| BLOOD BANK DRI-BATH (K760928) | Thermolyne Corp. | 1977-01-10 |
Recalls involving this device
No recalls on record reference this clearance.