510(k) DEN170029
- Device
- PrimeStore MTM
- Applicant
- Longhorn Vaccines and Diagnostics, LLC
- 510(k) number
- DEN170029
- Product code
- QBD
- Decision
- Unknown (DENG)
- Decision date
- 2018-03-19
- Date received
- 2017-05-24
- Regulation
- 866.2950
- Classification name
- Microbial Nucleic Acid Storage And Stabilization Device
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Jeff Fischer
- Address
- 2 Bethesda Metro Center, Suite 910 Bethesda MD US 20814 20814
FDA Registration Numbers#
- 3016635427
- 3009613136
- 3016764932
- 3003272500
- 3027266036
- 3010407203
- 1616487
- 3017101757
- 2436875
- 3004530258
- 3016838963
- 3009302820
- 3002444944
- 3025663244
- 3017830316
- 3013740892
- 3012758946
- 3031001098
- 3013373509
- 3013046485
- 3011818318
- 3017170972
- 3016741564
- 3017014794
- 1216735
Source Documents#
510(k) summary PDF not indicated by FDA
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