510(k) K923859
- Device
- PREMIER BLASTOMYCES
- Applicant
- MERIDIAN DIAGNOSTICS, INC.
- 510(k) number
- K923859
- Product code
- MJL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-10-05
- Date received
- 1992-07-31
- Regulation
- 866.3060
- Classification name
- Eia, Blastomyces Dermatitidis
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ALLEN D NICKOL
- Address
- 3471 River Hills Dr. Cincinnati OH US 45244 45244
FDA Registration Numbers#
- 1627497
Source Documents#
Other 510(k) Records For Product Code MJL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K840201 | EPIDURAL CATHETER TRAY | Aries Medical, Inc. | 1984-03-02 |
Legacy Summary#
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FDA Review#
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