RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE
FDA 510(k) clearance K072827 · decided 2007-11-26
Clearance details
- K-number
- K072827
- Device name
- RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE
- Applicant
- Remel, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-10-03
- Decision date
- 2007-11-26
- Days to decision
- 54 days
- Clearance type
- Traditional
- Product code
- MJE
- Device class
- 2
- Regulation number
- 866.1700
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Lenexa, KS, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.