WINTHROP PHARMACEUTICALS CONTRAST MEDIA WARMER
FDA 510(k) clearance K875275 · decided 1988-01-27
Clearance details
- K-number
- K875275
- Device name
- WINTHROP PHARMACEUTICALS CONTRAST MEDIA WARMER
- Applicant
- Sterling Drug, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-12-24
- Decision date
- 1988-01-27
- Days to decision
- 34 days
- Clearance type
- Traditional
- Product code
- JTQ
- Device class
- 1
- Regulation number
- 866.2540
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- New York, NY, US
- Third-party review
- No
- Expedited review
- No
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| 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.