ESP FOUR WELL TISSUE CULTURE PLATE, ESP SIX WELL TISSUE CULTURE PLATE, ESP MICRO SIX WELL TISSUE CULTURE PLATE, ESP WELL
FDA 510(k) clearance K994361 · decided 2000-02-18
Clearance details
- K-number
- K994361
- Device name
- ESP FOUR WELL TISSUE CULTURE PLATE, ESP SIX WELL TISSUE CULTURE PLATE, ESP MICRO SIX WELL TISSUE CULTURE PLATE, ESP WELL
- Applicant
- Genesis Industries, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-12-27
- Decision date
- 2000-02-18
- Days to decision
- 53 days
- Clearance type
- Traditional
- Product code
- MQK
- Device class
- 2
- Regulation number
- 884.6160
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Spring Valley, WI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.