510(k) K943051
- Device
- MYCOAKT M. TUBERCULOSIS CUULTURE ID KIT
- Applicant
- DYNAGEN, INC.
- 510(k) number
- K943051
- Product code
- JSY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-03-13
- Date received
- 1994-06-27
- Regulation
- 866.2660
- Classification name
- Kit, Identification, Mycobacteria
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- PETER J MIONE
- Address
- 99 Erie St., Cambridge MA US 02139 02139
FDA Registration Numbers#
- 2025606
- 2013736
- 2518071
- 3021841051
- 3005450604
- 3021010433
- 2247035
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JSY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K943049 | MYCOAKT M. AVIUM CULTURE ID KIT | Dynagen, Inc. | 1995-03-13 |
| K943050 | MYCOAKT M KANSASII CULTURE ID KIT | Dynagen, Inc. | 1995-03-13 |
| K880990 | ATS 0.2% BOVINE ALBUMIN FRACTION V SOLUTION | Alpha-Tec Systems, Inc. | 1988-03-24 |
| K830211 | API TB-IDENT* | Analytical Products, Inc. | 1983-03-24 |
Legacy Summary#
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FDA Review#
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