510(k) K860574
- Device
- GEN-PROBE MYCOPLASMA PNEUMONIA RAPID DETECT SYSTEM
- Applicant
- GEN-PROBE, INC.
- 510(k) number
- K860574
- Product code
- LQG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-07-03
- Date received
- 1986-02-14
- Regulation
- 866.3375
- Classification name
- Dna-reagents, Mycoplasma Spp.
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- DANIEL L KACIAN
- Address
- 9620 Chesapeake Dr. San Diego CA US 92123 92123
FDA Registration Numbers#
- 1419968
- 3004973408
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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