510(k) K831349
- Device
- STREPTOCOCUS ID PLATE
- Applicant
- GRANITE DIAGNOSTICS, INC.
- 510(k) number
- K831349
- Product code
- JST
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-05-16
- Date received
- 1983-04-25
- Regulation
- 866.2660
- Classification name
- Kit, Fastidious Organisms
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3013718871
- 1950204
- 3009637528
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JST #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K962423 | BBLCRYSTAL NEISSERIA/HAEMOPHILUS (N/H) SYSTEM | Becton Dickinson Microbiology Systems | 1996-08-02 |
| K854732 | API 50 CHB (CULTURE MEDIA) | Dms Products, Inc. | 1986-03-04 |
| K841661 | SYNTHETIC BROTH A.O.A.C. | Oxoid U.S.A., Inc. | 1984-05-11 |
| K832051 | RIM-HAEMOPHILUS 1 & 2 | Austin Biological Laboratories | 1983-08-12 |
| K832239 | RIM-HAEMOPHILUS 2 | Austin Biological Laboratories | 1983-08-12 |
Legacy Summary#
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FDA Review#
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