510(k) K883083
- Device
- MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM
- Applicant
- MEDICAL DIAGNOSTIC TECHNOLOGIES, INC.
- 510(k) number
- K883083
- Product code
- GSA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-10-25
- Date received
- 1988-07-21
- Regulation
- 866.3375
- Classification name
- Antisera, All Mycoplasma Spp.
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVID A WALL
- Address
- 3351 Wrightsboro Rd. Suite 502 Augusta GA US 30909 30909
FDA Registration Numbers#
- 2027113
- 3006091463
- 3017019647
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GSA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K950073 | MYCOPLASMA PNEUMONIAE ANTIBODY LATEX AGGLUTINATION TEST SYSTEM | Shared Systems, Inc. | 1995-10-17 |
| K910833 | COLOR VUE TM- MYCOPLASMA PNEUMONIAE | Seradyn, Inc. | 1991-06-24 |
| K905493 | MERISTAR-MP | Meridian Diagnostics, Inc. | 1991-01-30 |
| K903958 | SEROFAST | Intl. Mycoplasma/Mdc Assoc. | 1990-12-21 |
| K862630 | MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM | Medical Diagnostic Technologies, Inc. | 1986-09-03 |
Legacy Summary#
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FDA Review#
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