510(k) K072827
- Device
- RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE
- Applicant
- REMEL, INC.
- 510(k) number
- K072827
- Product code
- MJE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-11-26
- Date received
- 2007-10-03
- Regulation
- 866.1700
- Classification name
- Culture Media, Antifungal, Susceptibility Test
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Andre Hsiung
- Address
- 12076 Santa Fe Dr. Lenexa KS US 66215 66215
FDA Registration Numbers#
- 1924669
Source Documents#
Legacy Summary#
summary
FDA Review#
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